Gauffin 2014.
Study characteristics | ||
Methods |
Study design: single centre, parallel‐group, two‐arm, randomised, controlled trial Setting: orthopaedic department at the Linkoping University hospital, Sweden Trial time period: participants were enrolled between 4 March 2010 and 5 April 2012 Interventions: arthroscopic surgery plus unsupervised exercise versus unsupervised exercise Sample size calculations: the article did not describe how the sample size was estimated in this study. Analysis: intention‐to‐treat analysis was used; for those crossing over to the other group, an 'as‐treated' analysis was performed. |
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Participants |
Number of participants
Inclusion criteria
Exclusion criteria
Baseline characteristics Knee arthroscopy (N = 75)
Exercise therapy (N=75)
Pre‐treatment group differences: there were no differences in the baseline characteristics between the two groups |
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Interventions |
Arthroscopic surgery Arthroscopic surgery plus unsupervised exercise program. All operations were performed with full or local anaesthetics by an experienced arthroscopist at an independent daycare clinic. After the arthroscope was inserted in the joint and the joint was visually inspected, the surgeon judged, according to their experience, whether a meniscal resection or any other surgical treatment was indicated. After surgery, all participants were allowed immediate, full weight‐bearing activity. The participants were advised to resume the exercise programme according to phase 1 for 1 week, and then switch to phase 2. Phase 1 program was for 1 week and consisted of a brisk walk 20‐30 min, 10 x 2 sets of squats, pelvic lifts, pelvic lifts with ball between knees and extension of one knee, heel raise, wall squat, and standing on a pillow on one leg (30 sec x 2). Phase 2 was done twice a week for 3 months and consisted of 3 sets of all of the above‐mentioned exercises. Exercise Unsupervised exercise program. At an independent clinic, five physiotherapists experienced in knee rehabilitation gave individual instructions for the exercise programme. The exercise programme aimed to increase muscle function and postural control and was done twice a week for 3 months, unsupervised. Participants could exercise either at the gym or at home. Compliance was monitored with self‐reported exercise diaries. |
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Outcomes | Outcomes were measured at baseline, at 3 and 12 months, 3 years and 5 years of follow‐up. Primary outcome KOOS (Knee injury and Osteoarthritis Outcome Score) Pain subscale at 12 months, where scores range from 0 to 100 (100 indicates good knee function and less pain) Secondary outcomes
Outcomes included in this review at 3 and 12 months and at 5 years:
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Notes |
Funding: no funding source reported Trial registration: NCT01288768 Adverse events: Arthroscopic surgery Serious adverse events: No.(%): 3/66 (4.5%) Nature of event: two repeat arthroscopies in the surgery group ‐ one at 10 months and the other at 21 months after intervention. One participant died three years after surgery; it was not reported whether it was related to the intervention. Other adverse events: none reported Total adverse events: No.(%): 3/66 (4.5%) Exercise therapy Serious adverse events: none reported Other adverse events: none reported Total adverse events: none reported Knee surgery (replacement or osteotomy): not reported Progression of knee OA: radiographic deterioration from baseline to the 5‐year follow‐up, assessed according to the Kellgren‐Lawrence grade, occurred in 33/55 (60%) of the arthroscopy group and 10/27 (37%) of the exercise group. Withdrawals: no withdrawals were reported in this study; however, 9/75 in the arthroscopy group and 18/75 in the exercise group did not complete the 3‐month analysis; 5/75 in the arthroscopy group and 15/75 in the exercise group did not complete the 12‐month analysis; 9/75 in the arthroscopy group and 39/75 in the exercise group did not complete the 5‐year questionnaire and 20/75 in the arthroscopy group and 48/75 in the exercise group did not complete the 5‐year weight‐bearing radiographs. Reasons for lack of outcome data were not reported by group. Data analysis: ITT data were used for 3‐ and 12‐month follow‐up but only as‐treated data were reported at 5‐year follow‐up for outcomes: pain (Analysis 2.1), function (Analysis 2.2) and knee‐specific and generic quality of life (Analysis 2.3; Analysis 2.4) and participant reported success (Analysis 2.5). |
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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) | Low risk | "The orthopaedic surgeon who enrolled and assessed participants was blinded to the allocation sequence. The allocations were placed in sequentially numbered, opaque, sealed envelopes in 15 blocks, block size 10" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to group assignments. Blinding of physiotherapists was attempted but some participants revealed their group. Surgeons were not blinded |
Blinding of outcome assessor Self‐reported outcomes | High risk | Participants were not blinded to group assignments; thus, there was a risk of bias in the measurement of pain, function, knee‐specific quality of life, generic quality of life |
Blinding of outcome assessor Assessor‐reported outcome (knee replacement) | Low risk | It is unclear whether outcome assessors checking electronic medical files for adverse events at 12 months were blind to group allocation, but we judged outcome measurement unlikely to be influenced by lack of blinding. Blinding of radiologist assessing X‐rays not reported. Blinding of surgeon assessing X‐rays not done. Blinding of physiotherapists assessing functional tests (not used in our analysis) attempted but broken |
Incomplete outcome data (attrition bias) All outcomes | High risk | 9/75 in the arthroscopy group and 18/75 in the exercise group did not complete the 3‐month analysis; 5/75 in the arthroscopy group and 15/75 in the exercise group did not complete the 12‐month analysis; 8/74 in the arthroscopy group and 36/72 in the exercise group did not complete the 5‐year analysis (4 participants underwent surgery in the affected knee and were excluded from the study after 1 year). In the 3‐month assessment, 14 participants (per group information was not given) completed the questionnaire at 5 months and these data were excluded |
Selective reporting (reporting bias) | High risk | Authors have not collected or reported Tegner activity scale and have collected but not reported KOOS total score (secondary outcomes in the trial registration form) |
Other bias | Low risk | No other bias apparent |