Herrlin 2007.
Study characteristics | ||
Methods |
Study design: single centre, parallel‐group, two‐arm, randomised, controlled trial Setting: Capio Artro Clinic, Stockholm Sports Trauma Research Center, Sweden Trial time period: participants were enrolled between June 2003 and April 2005 Interventions: arthroscopic surgery plus supervised exercise versus supervised exercise Sample size calculations: sample size calculations reported that 40 participants per group were needed to detect an average difference of 10 points in the KOOS with 80% power. P = 0.05 was considered to be statistically significant. Analysis: intention‐to‐treat |
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Participants |
Number of participants
Inclusion criteria
Exclusion criteria
Baseline characteristics Arthroscopy (N = 47)
Exercise (N = 49)
Pre‐treatment group differences: there were no differences in baseline characteristics between the two groups |
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Interventions |
Arthroscopic surgery
Arthroscopic partial meniscectomy plus supervised exercise. Arthroscopy was performed on an outpatient basis by two experienced surgeons, majority under local anaesthesia. A 5.5 mm, 30, arthroscope was used with a pressure‐controlled irrigation system. A standard operation protocol was used to document possible findings in cartilage, ligaments, synovium and the medial and lateral meniscus. Meniscal lesions were registered and changes in the articular cartilage were classified according to the Outerbridge classification: grade 0 = intact articular surfaces, grade I = softening of the surfaces, grade II = partial‐thickness defects less than 1.5 cm, grade III = partial‐thickness tears greater than 1.5 cm/fragmentation, grade IV = exposed bone. Twice a week during a period of 8 weeks, each participant followed a standardised exercise programme which consisted of exercises for improving muscle strength and endurance, muscle flexibility, balance and proprioception. The goal of the exercise programme was to reduce pain, restore full ROM and improve knee function. The participants were informed to exert the exercises with some strain but perform them almost pain‐free and without having any negative influence in the affected knee at the following day. If the participant could tolerate the exercises without any problems, he/she performed the exercises with increasing weights and higher resistance. Exercise Supervised exercise programme. Each participant followed a standardised exercise programme with the possibility for individual adaptation twice a week for a period of 8 weeks, as described above. |
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Outcomes | Outcomes were measured at baseline and at 2, 6, 12, 24 and 60 months' follow‐up (the published papers reported at 2, 6, 24 and 60 months; author supplied 12‐month data upon request). Outcomes
Outcomes used in this review at 2 and 6 months, 2 and 5 years
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Notes |
Funding: not reported Trial registration: not done Adverse events: Arthroscopic surgery Serious adverse events: No. (%): 3/47 (6.4%) Three participants had an additional arthroscopy between 13 and 40 months after the initial operation. Re‐arthroscopy showed degenerative articular changes. Other adverse events: 0/47 (0%) Total adverse events: 3/47 (6.4%) 3 participants from the arthroscopy group had an additional arthroscopic procedure between 13 and 40 months following the original surgery. Exercise Serious adverse events: 13/49 (26.5%) 13 participants presented with medial meniscal tears on arthroscopic examination and were treated with partial meniscectomy. Other adverse events: 0/49 (0%) Total adverse events: 13/49 (26.5%) Cross‐overs: 13 participants from the exercise group had an arthroscopy at an average of 6.5 months after the intervention. Knee surgery (replacement or osteotomy): not reported Progression of knee OA: 2/43 participants from the arthroscopy group and 2/45 participants from the exercise group who had radiographic examination at 60 months after the intervention had progression of knee osteoarthritis in the medial compartment. In three cases, progression was from grade 1 to grade 2 and in one case from grade 1 to grade 3 (the authors did not specify which treatment group the latter participant was from) Withdrawals: none Data analysis: KOOS Pain, KOOS ADL and KOOS QoL were extracted at 2, 6, 12 and 24 months based on data supplied by the author upon request; progression of knee osteoarthritis was extracted from published paper. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of sequence generation process provided |
Allocation concealment (selection bias) | Unclear risk | There was no reporting of allocation concealment in this study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and study personnel was not done |
Blinding of outcome assessor Self‐reported outcomes | High risk | As blinding of participants was not done, there is a risk of bias in the measurement of knee pain and function |
Blinding of outcome assessor Assessor‐reported outcome (knee replacement) | Low risk | No blinding of study personnel but the assessor‐reported outcomes, adverse events and progression of knee OA based on radiographic examination, are unlikely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants who completed baseline measurements completed follow‐up assessments at 8 weeks and 6 months. 4 participants were lost to follow‐up at 24 months (1 from arthroscopy group and 3 from exercise group) and 4 participants were lost to follow‐up at 60 months (2 from arthroscopy group and 2 from exercise group) |
Selective reporting (reporting bias) | High risk | Trial registration not done. 12‐month outcomes were not reported in the trial publications |
Other bias | Low risk | No other bias apparent |