ORTHOPEDIC STUDIES










Early ACL Reconstruction vs Delayed Optional Reconstruction in Acute ACL Tear, NEJM (2010) [PubMed abstract]
  • A study in the NEJM enrolled 121 young, active adults with an acute ACL tear
Main inclusion criteria
  • Active individuals
  • 18 - 35 years of age
  • ACL tear not more than 4 weeks old to a previously uninjured knee
Main exclusion criteria
  • Professional athletes
  • Patients who were less than moderately active
  • Total collateral ligament rupture
  • Full thickness cartilage lesion
Baseline characteristics
  • Average age - 26 years
  • Meniscal injury - 55%
  • Average KOOS4 score - 37
Randomized treatment groups
  • Group 1 (62 patients): Rehabilitation plus ACL reconstruction within 10 weeks (ACL repair group)
  • Group 2 (59 patients): Rehabilitation plus optional delayed ACL reconstruction (PT group)
  • In both groups, meniscal tears were treated as indicated based on MRI findings and clinical signs. In Group 1, there were 40 meniscal surgeries over the course of the study. In Group 2, there were 50 meniscal surgeries.
Primary outcome: Change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) — pain, symptoms, function in sports and recreation, and knee-related quality of life (KOOS4; range of scores, 0 [worst] to 100 [best])
Results

Duration: At 2 years, the following was seen
Outcome ACL repair PT 1 vs 2
Primary outcome (average change in KOOS4 score) 39.2 39.4 p=0.96
Return to preinjury activity level or higher 44% 36% p=0.37
  • Over the course of the study, one subject in the ACL repair group did not have surgery, and 23 subjects (39%) in the PT group underwent ACL repair
  • As-treated analysis (average change in KOOS4 score): ACL repair (n=60) - 39, PT group with surgery (n=23) - 39.8, PT group without surgery (n=36) - 39.2 (p=0.98)
  • As-treated analysis (return to previous activity): ACL repair (n=60) - 44%, PT group with surgery (n=23) - 30%, PT group without surgery (n=36) - 39% (p=0.56)

Findings: In young, active adults with acute ACL tears, a strategy of rehabilitation plus early ACL reconstruction was not superior to a strategy of rehabilitation plus optional delayed ACL reconstruction. The latter strategy substantially reduced the frequency of surgical reconstructions.
Early ACL Reconstruction vs Delayed Optional Reconstruction - 5 year follow-up results, BMJ (2013) [PubMed abstract]
  • In the trial above, 120 of the 121 original participants were followed for 5 years. Results at 5 years are presented below.

Duration: After 5 years, the following was seen
Outcome ACL repair PT 1 vs 2
Primary outcome (KOOS4 score at 5 years) 80 82 p=0.45
Return to preinjury activity level 23% 20% p=0.73
  • In the PT group, seven additional subjects ended up having surgical ACL repair from years 2 - 5 bringing the total number of ACL repairs in the PT group to 30 patients (51%)
  • As-treated analysis (KOOS4 score at 5 years): ACL repair (n=59) - 80, PT group with surgery (n=30) - 81, PT group without surgery (n=29) - 82 (p=0.80)
  • There was no significant difference in radiographic osteoarthritis between the two groups

Findings: In this first high quality randomised controlled trial with minimal loss to follow-up, a strategy of rehabilitation plus early ACL reconstruction did not provide better results at five years than a strategy of initial rehabilitation with the option of having a later ACL reconstruction. Results did not differ between knees surgically reconstructed early or late and those treated with rehabilitation alone. These results should encourage clinicians and young active adult patients to consider rehabilitation as a primary treatment option after an acute ACL tear.
Early ACL Repair vs PT with Optional Repair After 3 Months, BMJ (2021) [PubMed abstract]
  • The study enrolled 167 patients with a complete ACL tear that occurred within the last 2 months
Main inclusion criteria
  • Age 18 - 65 years
  • Acute (within 2 months) ACL tear
Main exclusion criteria
  • History of injury to ACL of the contralateral knee
  • Dislocated bucket handle lesion of the meniscus with an extension deficit
Baseline characteristics
  • Average age 31 years
  • Female sex - 40%
  • Average BMI - 24.7
  • ACL injured during sport - 88%
  • Average IKDC score - 46
  • Other MRI findings: Meniscal tear - 45% | MCL injury - 36% | LCL injury - 11% | Cartilage defect - 24%
Randomized treatment groups
  • Group 1 (85 patients): Early ACL repair (within 6 weeks of randomization)
  • Group 2 (82 patients): Three months of PT followed by optional repair
Primary outcome: Patients’ perceptions of symptoms, knee function, and ability to participate in sports, measured by the International Knee Documentation Committee (IKDC) score, assessed over a period of 24 months. A higher IKDC score reflects a more favourable rating for symptoms, knee function, and ability to participate in sporting activities (optimum score 100).
Results

Duration: 2 years
Outcome Early repair PT + Optional repair Comparisons
ACL repair performed 96.5% 50% N/A
Primary outcome (IKDC at 2 years) 84.7 79.4 Diff 5.3, 95%CI [0.6 - 9.9], p=0.026
IKDC at 12 months 81.6 74.4 Diff 7.1, 95%CI [1.9 - 12.4]
Meniscal repair procedures 24 17 N/A

Findings: In patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction.






FIDELITY Study - Surgical Repair vs Sham Surgery for Medial Meniscal Tear, NEJM (2013) [PubMed abstract]
  • The FIDELITY study enrolled 146 patients with a symptomatic medial meniscal tear
Main inclusion criteria
  • Age 35 - 65 years
  • Knee pain > 3 months that was unresponsive to conservative treatment
  • Clinical findings consistent with a medial meniscal tear
  • MRI was performed on all patients to confirm the presence of a meniscal tear, but trial eligibility was only confirmed once the tear was observed on arthroscopy
Main exclusion criteria
  • Traumatic onset of symptoms
  • Osteoarthritis
Baseline characteristics
  • Average age 52 years
  • Average BMI 27
  • Median duration of pain - 10 months
  • Pain onset: Gradual 63 - 69% | After exercise or hard work 17% | Suddenly or after twisting 14 - 18%
  • Symptoms of catching or locking - 47%
  • Average Lysholm score - 60
  • Average WOMET score - 54
  • Average knee pain score after exercise - 6
Randomized treatment groups
  • Group 1 (70 patients): Medial meniscus repair
  • Group 2 (76 patients): Sham repair (repair was faked, nothing was actually done to meniscus)
Primary outcome: Changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure
Results

Duration: 12 months
Outcome Meniscal repair Sham Comparisons
Average Lysholm score improvement 21.7 23.3 diff -1.6, 95%CI [-7.2 to 4.0]
Average WOMET score improvement 24.6 27.1 diff -2.5, 95%CI [-9.2 to 4.1]
Average knee pain score improvement 3.1 3.3 diff -0.1, 95%CI [-0.9 to 0.7]
  • A subgroup of patients (Meniscal repair - 14 patients, Sham - 18 patients) had acute onset of symptoms. When these patients were analyzed separately, there was no significant difference in their outcomes, although this analysis was underpowered.
  • Two patients in the meniscal repair group required additional knee surgery, and five patients in the sham group eventually had knee surgery. This difference was nonsignificant.

Findings: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure.
FIDELITY Study - Surgical Repair vs Sham Surgery for Medial Meniscal Tear - Two-year Follow-up, BMJ (2018) [PubMed abstract]
  • In the FIDELITY study above, 144 of the original 146 participants were followed for 2 years. Results at 2 years are presented below

Duration: 2 year follow-up
Outcome Meniscal repair Sham Comparisons
Average Lysholm score improvement 23.1 26.3 diff -3.2, 95%CI [-8.9 to 2.4]
Average WOMET score improvement 27.3 31.6 diff -4.3, 95%CI [-11.3 to 2.6]
Average knee pain score improvement 3.5 3.9 diff -0.4, 95%CI [-1.3 to 0.5]

Findings: In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after meniscal repair were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from meniscal repair.


Surgical Meniscal Repair vs Physical Therapy in Patients with Meniscal Tear and OA, NEJM (2013) [PubMed abstract]
  • The trial enrolled 351 patients with a symptomatic meniscal tear and osteoarthritis
Main inclusion criteria
  • One month of meniscal tear symptoms (defined as at least one of the following: clicking, catching, popping, giving way, pain with pivot or torque, episodic pain, pain that is acute and localized to one joint line)
  • Age ≥ 45 years
  • Evidence of mild-to-moderate osteoarthritis on X-ray or MRI
  • Meniscal tear on MRI
Main exclusion criteria
  • Severe osteoarthritis
  • Locked knee
Baseline characteristics
  • Average age 58 years
  • Average BMI - 30
  • Average baseline WOMAC score - 37
  • OA severity: None - 21% | Possible OA - 18% | Mild - 23% | Moderate - 26%
Randomized treatment groups
  • Group 1 (161 patients): Surgical meniscal repair followed by physical therapy
  • Group 2 (169 patients): Physical therapy with option for later surgical meniscal repair if needed
Primary outcome: Difference between groups in change in score from baseline on the WOMAC Index (ranging from 0 to 100, with higher scores indicating more severe symptoms) at 6 months
Results

Duration: 12 months
Outcome Meniscal repair Physical therapy Comparisons
Change in WOMAC at 6 months 20.9 18.5 diff 2.4, 95%CI [-1.8 to 6.5]
Change in WOMAC at 12 months 23.5 22.8 diff 0.7, 95%CI [-3.5 to 4.9]
  • There was no significant difference in pain scores between the two groups
  • In the physical therapy group, 30% of the patients had surgery (crossovers) at 6 months, and 35% by 12 months
  • In the surgery group, 5.6% of patients had not undergone surgery by 6 months
  • An as-treated analysis found no difference between the two groups at 6 and 12 months

Findings: In the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months.






Steroid Injection vs Placebo Injection for Knee OA, JAMA Internal Medicine (2015) [PubMed abstract]
  • A JAMA Internal Medicine trial enrolled 100 patients with knee OA
Main inclusion criteria
  • Age ≥ 40 years
  • Radiographic confirmation of clinical OA of the knee
  • Clinical signs of localized inflammation in the knee
  • Knee pain during walking (score > 4 on a scale of 0 - 10 with 10 being the worst)
  • BMI ≤ 35
Main exclusion criteria
  • Steroid injection or exercise therapy within 3 months
  • Oral steroids within 4 weeks
  • Inflammatory arthritis
  • Fibromyalgia
  • Spinal nerve root compression
Baseline characteristics
  • Average age 63 years
  • Female - 61%
  • Average BMI - 29
  • Average KOOS pain subscale score - 54
  • Average KOOS function score - 62
  • OA grade on X-ray: Possible - 4% | Mild - 39% | Moderate - 32% | Severe - 25%
Randomized treatment groups
  • Group 1 (50 patients): Knee injection of saline mixed with 4 ml of lidocaine
  • Group 2 (50 patients): Knee injection of methylprednisolone 40 mg mixed in 4 ml of lidocaine
  • Patients in both groups started a 12-week supervised exercise program 2 weeks after the injection
Primary outcome: Change from baseline in the pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (range 0 - 100, higher scores indicate less pain) at Week 14
Results

Duration: 14 weeks
Outcome Saline Steroid Comparisons
Primary outcome (change in KOOS score at Week 14) 14.8 13.6 diff 1.2, 95%CI [-3.8 to 6.2], p=0.64
Change in KOOS pain score at Week 2 4.5 5.0 diff -0.5, 95%CI [-5.5 to 4.5], p=0.85
Number of squats in 30 seconds at Week 14 9.0 6.6 diff 2.4, 95%CI [-1.5 to 6.2], p=0.23
Change in KOOS function score at Week 14 15 14.9 diff 0.1, 95%CI [-4.6 to 4.8], p=0.96
  • Patients also had MRIs performed at baseline and Week 14. There was no significant difference in MRI-assessed synovitis between the groups.

Findings: No additional benefit results from adding an intra-articular injection of 40 mg of corticosteroid before exercise in patients with painful OA of the knee. Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments.
Steroid Injections vs Saline Injections every 3 Months for 2 years for Knee OA, JAMA (2017) [PubMed abstract]
  • A JAMA trial enrolled 140 patients with knee OA
Main inclusion criteria
  • Age ≥ 45 years
  • OA based on American College of Rheumatology criteria (knee pain with evidence of OA on X-ray)
  • Ultrasound evidence of effusion synovitis in the study knee
Main exclusion criteria
  • Other systemic inflammatory joint disease
  • Chronic or recent use of oral corticosteroids, doxycycline, indomethacin, glucosamine, or chondroitin
  • Recent (<3 months) intraarticular corticosteroids or hyaluronic acid
Baseline characteristics
  • Average age 58 years
  • Female - 53%
  • Average BMI - 31
  • Average WOMAC pain score - 8.3
  • Average WOMAC function scale - 29
Randomized treatment groups
  • Group 1 (70 patients): Knee injection of triamcinolone 40 mg every 12 weeks for 2 years
  • Group 2 (70 patients): Knee injection of saline every 12 weeks for 2 years
  • Local anesthetic was not used with injections
  • Participants were advised to take acetaminophen only if needed
  • Participants were asked to discontinue concomitant analgesics 2 days before each assessment to avoid masking symptoms of pain
Primary outcomes:
  • 1. Annual knee magnetic resonance imaging for quantitative evaluation of cartilage volume
  • 2. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis index collected every 3 months (Likert pain subscale range, 0 [no pain] to 20 [extreme pain])
Results

Duration: 2 years
Outcome Steroid Saline Comparisons
Change in average cartilage thickness -0.29 mm -0.13 mm diff 0.16 mm, 95%CI [-0.31 to -0.01], p=0.04
Change in WOMAC pain score -1.2 -1.9 diff 0.64, 95%CI [-1.6 to 0.29], p=0.17
Change in WOMAC function score -4.1 -5.1 diff 1.01, 95%CI [-4.9 to 2.9], p=0.59
  • There was no significant difference in new or worsening hypertension between the groups
  • Hemoglobin A1C levels declined in the triamcinolone but increased in the saline group (−0.1% vs 0.2%; between-group difference, −0.2; 95%CI [−0.5 to −0.007])

Findings: Among patients with symptomatic knee osteoarthritis, 2 years of intra-articular triamcinolone, compared with intra-articular saline, resulted in significantly greater cartilage volume loss and no significant difference in knee pain. These findings do not support this treatment for patients with symptomatic knee osteoarthritis.
Steroid Injections vs Physical Therapy for Knee OA, NEJM 2020 [PubMed abstract]
  • The study enrolled 156 patients with knee OA
Main inclusion criteria
  • Age ≥ 38 years
  • Meet ACR criteria for knee OA
  • Evidence of OA on X-ray
Main exclusion criteria
  • PT or steroid shot within 12 months
  • No evidence of OA on X-ray
  • History of gout in the knee
  • History of rheumatoid arthritis
Baseline characteristics
  • Average age 56 years
  • Female sex - 48%
  • Average BMI - 31.5
  • Average duration of symptoms - 7.6 years
  • Average WOMAC score - 108
  • Kellgren–Lawrence grade: 1 - 3.8% | 2 - 43.6% | 3 - 37.8% | 4 - 14.7%
Randomized treatment groups
  • Group 1 (78 patients): Steroid injections
  • Group 2 (78 patients): Physical therapy
  • In the steroid group, patients could receive up to 3 injections over the 1-year trial period
  • Steroid injections included 40 mg of triamcinolone and 7 mls of lidocaine 1%
  • In the PT group, patients underwent up to 8 treatment sessions over the initial 4-to-6-week period; the patient could attend an additional 1 to 3 sessions at the time of the 4-month and 9-month reassessments if that plan of care was agreed on by the physical therapist and the patient
Primary outcome: Total WOMAC score (range 0 - 240 with higher scores being worse) at 1 year
Results

Duration: 1 year
Outcome Steroid PT Comparisons
Average baseline total WOMAC score 108 107 N/A
Primary outcome (WOMAC at 1 year) 55.8 37 p=0.008
  • In the Steroid group, patients received an average of 2.6 injections over the course of the trial
  • In the PT group, 9% of patients also received a steroid injection. In the Steroid group, 18% of patients also received physical therapy.

Findings: Patients with osteoarthritis of the knee who underwent physical therapy had less pain and functional disability at 1 year than patients who received an intraarticular glucocorticoid injection.






Hyaluronic Acid Injection (Synvisc-One®) vs Steroid Injections for Knee OA, The Journal of Bone and Joint Surgery (2016) [PubMed abstract]
  • A study in The Journal of Bone and Joint Surgery enrolled 99 patients with knee OA
Main inclusion criteria
  • Symptomatic knee OA according to American Rheumatism Association classification criteria
  • Dissatisfaction with conservative treatment (NSAIDs, oral analgesic drugs, physical therapy, or brace)
Main exclusion criteria
  • Lumbar spondylosis with radiculopathy
  • Bone-on-bone arthritis on X-ray
  • Varus or valgus deformity > 5°
  • Previous fracture or surgery on affected knee
  • Injection of affected knee within 6 months
Baseline characteristics
  • Average age 62 years
  • Average BMI - 26
  • Average pain visual analog score - 52
  • Average WOMAC score - 41
  • Average knee flexion - 125°
  • OA grade on X-ray: Possible OA - 22% | Mild - 22% | Moderate - 41% | Severe - 14%
Randomized treatment groups
  • Group 1 (50 patients): Knee injection of 6 ml of Hylan G-F 20 (Synvisc-One®)
  • Group 2 (49 patients): Knee injection of triamcinolone 40 mg mixed in 5 ml of 1% lidocaine with epinephrine
  • If knee effusion was present, it was aspirated at the time of injection
Primary outcome: Knee pain (assessed with visual analog scale, range 0 - 100 with higher number being worse pain), knee function (assessed with WOMAC index, range 0 - 96 with higher numbers being worse function), and knee range of motion at 6 months
Results

Duration: 6 months
Outcome Synvisc Steroid Comparisons
Primary outcome (pain score at 6 months) 24 21 diff 3, 95%CI [-6 to 11], p=0.60
Primary outcome (WOMAC score at 6 months) 21 21 diff 0, 95%CI [-8 to 6], p=0.81
Primary outcome (knee flexion at 6 months) 132° 133° diff -1, 95%CI [-5 to 2], p=0.43
Primary outcome (pain score at 1 week) 23 14 diff 9, 95%CI [1 to 15], p=0.018

Findings: Triamcinolone acetonide provided similar improvement in knee pain, function, and range of motion compared with hylan G-F 20 at the 6-month follow-up, with better pain control in the first week and better knee functional improvement in the second week.






Glucosamine and chondroitin studies

Pharmaceutical-grade Chondroitin Sulfate vs Celecoxib vs Placebo for Knee Osteoarthritis, BMJ (2017) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=604 | duration=6 months)
  • Treatment: Pharmaceutical-grade Chondroitin 800 mg once daily vs Celecoxib 200 mg once daily vs Placebo
  • Primary outcome: Change in pain on a 100 mm Visual Analogue Scale (VAS) and change in the Lequesne Index at 6 months
  • Results:
    • Primary outcome (VAS): Chondroitin -42.6, Celecoxib -39.5, Placebo -33.3 (p<0.05 for chondroitin or celecoxib vs placebo)
    • Primary outcome (Lequesne Index): Chondroitin -4.7, Celecoxib -4.6, Placebo -3.7 (p<0.05 for chondroitin or celecoxib vs placebo)
  • Findings: A 800 mg/day pharmaceutical-grade chondroitin sulfate is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis patients. This formulation of chondroitin should be considered a first-line treatment in the medical management of knee OA.

Chondroitin Sulfate + Glucosamine Sulfate vs Placebo for Knee Osteoarthritis, Arthritis and Rheumatology (2017) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=164 | duration=6 months)
  • Treatment: Chondroitin 1200 mg + Glucosamine 1500 once daily (CG) vs Placebo
  • Primary outcome: Mean change from baseline in the VAS global pain score (0 - 100 with 100 being greatest pain and 0 being no pain)
  • Results:
    • Primary outcome (VAS): CG -11.8, Placebo -20.5 (p<0.03, placebo superior)
  • Findings: The results of this trial demonstrate a lack of superiority of CS/GS combination therapy over placebo in terms of reducing joint pain and functional impairment in patients with symptomatic knee OA over 6 months. Further research might fully elucidate the suitability of CS/GS combination therapy in patients with OA

Glucosamine vs Chondroitin vs Chondroitin/Glucosamine vs Celecoxib vs Placebo for Knee Osteoarthritis - NEJM (2006) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=1583 | duration=24 weeks)
  • Treatment: Chondroitin 1200 mg (C) vs Glucosamine 1500 (G) vs Chondroitin/Glucosamine combined (CG) vs Celecoxib 200 mg once daily vs Placebo
  • Primary outcome: Proportion of patients with 20% decrease in knee pain from baseline to week 24
  • Results:
    • Primary outcome: C - 65.4%, G - 64%, CG - 66.6%, Celecoxib - 70.1%, Placebo - 60.1% (compared to placebo, only celecoxib was significantly better p=0.008)
  • Findings: Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain.











Total knee replacement durability
Years since replacement Original implant still in place
5 98%
10 95%
15 91%
20 86%
25 82%
Initial age of surgery Lifetime risk of revision
50 - 54 Men - 35%
Women - 20%
60 15%
> 70 years 5%
Other
  • Average age of cohort at replacement was 70 years except for 25-year data where average age was 68 years
  • Women had an overall lower risk of revision surgery
  • The risk for revision surgery was greatest in the first five years after the original surgery
  • The 25-year survival for a UKR was 70%




Steroid Injection vs Placebo Injection for Plantar Fasciitis, BMJ (2012) [PubMed abstract]
  • A study in the British Medical Journal enrolled 82 patients with plantar fasciitis
Main inclusion criteria
  • Inferior heel pain for ≥ 8 weeks
  • Plantar fascia thickness of ≥ 4 mm on ultrasound (indicator of inflammation)
Main exclusion criteria
  • Steroid injection for plantar fasciitis within previous 6 months
  • Diabetes
  • History of trauma to heel
  • Other therapy for plantar fasciitis within 4 weeks
Baseline characteristics
  • Average age 52 years
  • Average BMI 31
  • Median duration of symptoms: Steroid group - 9 months | Placebo group - 12 months
  • Bilateral plantar fasciitis - 29%
Randomized treatment groups
  • Group 1 (41 patients): Ultrasound-guided steroid injection of plantar fascia (4 mg of dexamethasone)
  • Group 2 (41 patients): Ultrasound-guided placebo injection
Primary outcome: Pain and plantar fascia thickness at 4, 8, and 12 weeks. Pain was measured by the foot pain domain of the foot health status questionnaire. This instrument has four domains (pain, function, footwear, and general foot health), with each scored on a 0 - 100 point scale, where 0 represents the worst foot health and 100 the best foot health.
Results

Duration: 12 weeks
Outcome Steroid Placebo Comparisons
Baseline foot health status score 37 36 N/A
Foot health status score (4 weeks) 59 48 diff 10.9 95%CI [1.4 - 20.4], p=0.03
Foot health status score (8 weeks) 62 56 diff 5.6 95%CI [-4.5 to 15.6], p=0.28
Foot health status score (12 weeks) 65 60 diff 5 95%CI [-5.7 to 16.3], p=0.34
  • Plantar fascia thickness was significantly less in the steroid group at all 3 time points

Findings: A single ultrasound guided dexamethasone injection is a safe and effective short term treatment for plantar fasciitis. It provides greater pain relief than placebo at four weeks and reduces abnormal swelling of the plantar fascia for up to three months. However, clinicians offering this treatment should also note that significant pain relief did not continue beyond four weeks.










Autologous Blood Injection vs Sham Injection for Achilles Tendonitis, BMJ (2013) [PubMed abstract]
  • A study in the British Medical Journal enrolled 53 patients with Achilles tendonitis
Main inclusion criteria
  • Symptoms of unilateral mid-portion Achilles tendinopathy for ≥ 3 months
  • Diagnosis confirmed by ultrasound
Main exclusion criteria
  • Bilateral symptoms
  • Previous Achilles rupture or surgery
  • Previous adjuvant therapy
Baseline characteristics
  • Average age 48 years
  • Average duration of symptoms: Treatment group - 23 months | Control - 39 months
  • Moderate changes on US: Treatment group - 62% | Control - 63%
  • Severe changes on US: Treatment group - 19% | Control - 4%
Randomized treatment groups
  • Group 1 (26 patients): Two injections (one month apart) of patient's own blood (3 ml) into site of maximal Achilles' tenderness
  • Group 2 (27 patients): Two placebo injections 1 month apart
  • All participants were instructed to do 180 heel drops over a step each day. Subjects were allowed to exercise as long as it did not induce pain.
Primary outcome: Change in the Victorian Institute of Sports Assessment-Achilles (VISA-A) score measured at baseline and again at one, two, three, and six months. Scores range from 0-100 with 100 indicating a symptom-free tendon.
Results

Duration: 6 months
Outcome Blood Placebo Comparisons
Baseline score 58 57 N/A
Change in VISA-A (one month) +7.9 +5.3 diff 2.6, 95%CI [−3.4 to 8.6]
Change in VISA-A (two months) +12 +8.6 diff 3.4, 95%CI [−3.8 to 11]
Change in VISA-A (three months) +15.2 +14.9 diff 0.3, 95%CI [−6.9 to 7.5]
Change in VISA-A (six months) +18.7 +19.9 diff -1.2, 95% CI [−10 to 7.9]

Findings: The administration of two unguided peritendinous autologous blood injections one month apart, in addition to a standardised eccentric training programme, provides no additional benefit in the treatment of mid-portion Achilles tendinopathy.





PT vs Acromioplasty vs Rotator Cuff Repair + Acromioplasty for Symptomatic Supraspinatus Tear, J Bone Joint Surg (2015) [PubMed abstract]
  • A study in the The Journal of Bone and Joint Surgery enrolled 180 shoulders with nontraumatic, symptomatic, supraspinatus tears
Main inclusion criteria
  • Age ≥ 55 years
  • Nontraumatic, symptomatic, isolated full-thickness supraspinatus tendon tear documented with MRI
  • Full range of motion in shoulder
Main exclusion criteria
  • Tear involving entire tendon
  • Tears of other tendons
  • Glenohumeral osteoarthritis visible on X-ray
Baseline characteristics
  • Average age 65 years
  • Average duration of symptoms - 27 months
Randomized treatment groups
  • Group 1 (60 patients): Physical therapy that included written instructions and 10 monitored sessions (PT group)
  • Group 2 (60 patients): Acromioplasty + physical therapy (A/PT group)
  • Group 3 (60 patients): Acromioplasty + supraspinatus repair + physical therapy (A/R/PT group)
Primary outcome: Change in the absolute Constant score at 2 years. The Constant score is the sum of four subscores (pain, activities of daily living, range of motion, and strength). Higher scores mean less pain and better function. Scale goes from 0 (worst) to 100 (best).
Results

Duration: 2 years
Outcome PT A/PT A/R/PT Comparisons
Baseline Constant score 58 60 58 N/A
Primary outcome +18.4 +20.5 +22.6 p=0.38 for difference between groups
  • There was no significant difference between the groups in the visual analog scale for pain (p=0.45)
  • Patients satisfaction was high in all 3 groups (PT - 89%, A/PT - 95%, A/R/PT - 94%)
  • Five patients crossed over from the PT group to surgical treatment
  • Average change in supraspinatus tear on MRI from baseline to 2 years was smaller in the A/R/PT group (PT group: 9.6 mm at baseline to 10.4 mm at 2 years | A/PT group: 9.1 mm at baseline to 11.7 mm at 2 years | A/R/PT group: 8.4 mm at baseline to 4.2 mm at 2 years)

Findings: There was no significant difference in clinical outcome between the three interventions at the two-year follow-up. The potential progression of the rotator cuff tear, especially in the non-repaired treatment groups, warrants further follow-up. On the basis of our findings, conservative treatment is a reasonable option for the primary initial treatment for isolated, symptomatic, nontraumatic, supraspinatus tears in older patients.






Surgery vs Sham Surgery vs No Treatment for Shoulder Impingement Syndrome, Lancet (2017) [PubMed abstract]
  • A study published in the Lancet enrolled 313 patients with impingement syndrome
Main inclusion criteria
  • Subacromial pain for ≥ 3 months with intact rotator cuff tendons
  • Completed exercise therapy and ≥ 1 steroid injection
Main exclusion criteria
  • Full-thickness torn rotator cuff (partial-thickness tear was allowed)
Baseline characteristics:
  • Average age 53 years
  • Average number of shoulder injections received - 2
  • Average Oxford Shoulder Score - 26
Patients were randomized to one of three groups:
  • Group 1 (106 patients): Arthroscopic subacromial decompression surgery
  • Group 2 (103 patients): Sham surgery
  • Group 3 (104 patients): No treatment
  • The sham surgery group had arthroscopy performed but no removal of bone or soft tissue was performed
  • Study was performed at 32 hospital sites with 51 participating surgeons
  • Patients in the Groups 1 and 2 received postoperative physical therapy but Group 3 did not
Primary outcome: Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat
Results

Duration: 12 months
Outcome Surgery Sham No treatment Comparisons
Baseline Oxford Score 25 27 26 N/A
Primary outcome (6 months) 32.7 34.2 29.4 1 vs 2 p=0.31 | 1 vs 3 p=0.019 | 2 vs 3 p=0.0014
Primary outcome (12 months) 38.2 38.4 34.3 1 vs 2 p=0.85 | 1 vs 3 p=0.020 | 2 vs 3 p=0.019
  • In the Surgery group, 21% of patients had not received surgery at 6 months. At 12 months, 16% had not received surgery.
  • In the Sham surgery group, 11% of patients had received some type of shoulder surgery (non-sham) and 31% had not received any surgery (sham or real) at 6 months. At 12 months, 11% of patients had received some type of shoulder surgery (non-sham) and 22% had not received any surgery (sham or real).
  • In the No treatment group, 11% of patients had received some type of shoulder surgery at 6 months. At 12 months, 24% of patients had received some type of shoulder surgery.
  • In a per-protocol analysis, there was no significant difference between the Surgery group and Sham surgery group at 6 months (p=0.69) and 12 months (p=0.35)

Findings: Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process.











Steroid Injection vs PT vs Steroid Injection + PT vs Placebo for Tennis Elbow, JAMA (2013) [PubMed abstract]
  • A study in the JAMA enrolled 165 patients with tennis elbow
Main inclusion criteria
  • Tennis elbow for > 6 weeks
  • Pain provoked by wrist extension
Main exclusion criteria
  • Recent injection within 6 months
  • Recent PT within 3 months
  • Concomitant neck or arm pain
Baseline characteristics
  • Average age 49 years
  • Median duration of symptoms - 16 weeks
  • Male sex - 62%
Randomized treatment groups
  • Group 1 (43 patients): Steroid injection
  • Group 2 (40 patients): Steroid injection + PT
  • Group 3 (41 patients): Placebo injection
  • Group 4 (41 patients): Placebo injection + PT
  • Steroid injection consisted of 1 ml of 10 mg/ml triamcinolone + 1 ml of 1% lidocaine
  • PT consisted of eight 30 minute sessions of treatment during an 8-week period
Primary outcomes: 1-year global rating of change scores of complete recovery or much improvement, and 1-year recurrence (defined as global rating of change scores of complete recovery or much improvement at 4 or 8 weeks, but not at 8, 12, 26, or 52 weeks)
Results

Duration: 52 weeks
Outcome Steroid Steroid + PT Placebo Placebo + PT
Complete recovery or much improvement 84% 82% 93% 100%
  • Steroid injections were significantly worse than placebo injections (RR for better outcome, steroid vs placebo - 0.86, 99%CI [0.75 - 0.99])
  • PT had no significant effect (RR for better outcome, PT vs none - 1.04 99%CI [0.90 - 1.19], p=0.56)
  • There was no significant interaction between PT and steroid injection
One-year recurrence 55% 54% 20% 5%
  • Steroid injections caused significantly more recurrence than placebo (RR of recurrence, placebo vs steroid - 0.23 99%CI [0.10 - 0.51])
  • PT had no significant effect on recurrence (RR for less recurrence, PT vs none - 1.31 [99%CI, 0.73 - 2.35], p=0.25)
  • At 4 weeks, both steroid injections and PT were significantly better than placebo and no PT, respectively, for recovery or much improvement
  • At 26 weeks, steroid injections were worse than placebo for recovery or much improvement, and PT had no significant effect
  • In the steroid group, 4 patients had skin depigmentation and 3 had subcutaneous fat atrophy

Findings: Among patients with chronic unilateral lateral epicondylalgia, the use of corticosteroid injection vs placebo injection resulted in worse clinical outcomes after 1 year, and physiotherapy did not result in any significant differences





Steroid injection vs Physical Therapy vs Observation for Trochanteric Bursitis, BMJ (2018) [PubMed abstract]
  • The trial enrolled 204 patients with trochanteric bursitis
Main inclusion criteria
  • Age 35 - 70 years
  • Lateral hip pain for > 3 months
  • Gluteal tendinopathy confirmed by MRI
Main exclusion criteria
  • Low back pain and/or sciatica
  • Steroid injection within 12 months
  • Hip replacement
Baseline characteristics
  • Average age - 55 years
  • Female sex - 82%
  • Average BMI - 27
  • Average symptom duration - 24 months
Randomized treatment groups
  • Group 1 (69 patients) - Physical therapy
  • Group 2 (66 patients) - Ultrasound-guided steroid injection into affected trochanter bursa
  • Group 3 (69 patients) - Observation
  • Betamethasone 5.7 mg or triamcinolone 40 mg were used for the steroid injection along with bupivacaine
  • Exercise group had 14 individual sessions over eight weeks
  • The observation group received general information about the condition
  • Treatment was open-label
Primary outcome: Patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at eight weeks, with longer term follow-up at 52 weeks
Results

Duration: 52 weeks
Outcome PT Steroid Obs Comparisons
Primary outcome (success at 8 weeks) 77% 58% 29% 1 vs 2, p=0.01 | 1 vs 3 p<0.001 | 2 vs 3 p<0.001
Primary outcome (pain at 8 weeks) 1.5 2.7 3.8 1 vs 2, p=0.003 | 1 vs 3 p<0.001 | 2 vs 3 p<0.001
Primary outcome (success at 52 weeks) 78% 57% 52% 1 vs 2, p=0.01 | 1 vs 3 p<0.001 | 2 vs 3 p=0.46
Primary outcome (pain at 52 weeks) 2.1 2.3 3.2 1 vs 2, p=0.53 | 1 vs 3 p=0.006 | 2 vs 3 p=0.034

Findings: For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support education plus exercise as an effective management approach for gluteal tendinopathy.







Total hip replacement durability
Years since replacement Original implant still in place
5 98%
10 95%
15 89%
20 81%
25 58 - 78%
Initial age of surgery Lifetime risk of revision
50 - 54 Men - 30%
Women - 17%
60 15%
> 70 years 8%
Other
  • Average age of cohort at replacement was 69 years
  • Women had an overall lower risk of revision surgery




Surgical vs Nonsurgical Treatment of Displaced Proximal Humerus Fracture, JAMA (2015) [PubMed abstract]
  • A study in the JAMA enrolled 250 patients with a displaced proximal humerus fracture
Main inclusion criteria
  • Age ≥ 16 years
  • Fracture occurred within 3 weeks
  • Displaced humerus fracture involving the surgical neck
  • Enough displacement to consider surgery
Main exclusion criteria
  • Associated dislocation of the injured shoulder joint
  • Open fracture
  • Clear indication for surgery such as severe soft-tissue compromise
Baseline characteristics
  • Average age 66 years
  • Average time since injury - 5.7 days
  • Fracture characteristics: One-part fractures 7% | Two-part fractures - 50% | Three-part fractures - 36% | Four-part fractures 4.5%
Randomized treatment groups
  • Group 1 (125 patients): Either internal fracture fixation (eg. with plate and screws) that preserved the humeral head or humeral head replacement (hemiarthroplasty)
  • Group 2 (125 patients): Sling for injured arm for as long as needed (3 weeks was suggested) followed by active rehabilitation
Primary outcome: The Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed and averaged over a 2-year period, with assessment and data collection at 6, 12, and 24 months
Results

Duration: 2 years
Outcome Surgery Sling + PT Comparisons
Primary outcome 39 38 diff 0.75, 95%CI [−1.33 to 2.84 points], p=0.48)
  • In the surgical group, 16 (13%) patients were treated nonsurgically. In the nonsurgical group, 2 (2%) patients received surgery.
  • In the surgery group, 90 patients received locking plates and screws, 10 received hemiarthroplasty, and 9 received other surgeries
  • There was no significant difference at any individual time point between the two groups
  • 11 patients in both groups received secondary shoulder surgery during follow-up

Findings Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus.