Osteras 2012.
Study characteristics | ||
Methods |
Study design: multicentre, two‐arm, randomised controlled trial Setting: two orthopedic clinics in two hospitals in Norway Trial time period: participants were recruited over a period of one year; however, the exact time frame was not mentioned. Interventions: arthroscopic surgery versus exercise Sample size calculations: based on a pre‐determined difference between treatment groups of 20% change in pain on a 10‐cm visual analogue scale and a standard deviation of 1.5 cm, 10 participants were required in each group to have 80% power to detect the 20% difference as statistically significant at the level of P < 0.05. Analysis: intention‐to‐treat |
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Participants |
Number of participants
Inclusion criteria
Exclusion criteria
Baseline characteristics Arthroscopic partial meniscectomy
Medical exercise therapy
Pre‐treatment group differences: there were no obvious differences in baseline characteristics between the two groups. |
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Interventions |
Arthroscopic surgery Arthroscopic partial meniscectomy. A standard arthroscopic partial meniscectomy was applied as a surgical intervention, which was carried out at two hospitals in Trondheim, Norway, and performed on participants who fulfilled inclusion criteria and were randomised to surgical treatment. Normal procedures for this surgery at the respective hospitals were followed, the protocols did not differ between the hospitals, and there were two surgeons involved. Exercise Supervised (medical) exercise therapy. The exercise program was developed for this particular study, with a focus on co‐ordination and muscle function training, along with pain modification exercise therapy. The program was for 3 months, and participants exercised 3 times per week. Each treatment in the exercise group started with 15 to 20 minutes of aerobic work on a stationary ergometer cycle. After 4 exercises each of 3 sets of 30 repetitions halfway through the exercise program, the subjects cycled for 10 minutes and again after the last 4 exercises, the participants did another 10 minutes on a stationary ergometer cycle. |
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Outcomes | Outcomes were measured at baseline and at 3 months of follow‐up. Primary outcome Pain in the last week measured with a visual analogue scale (VAS) at rest and recorded on a 0 to 10 cm line (0 = no pain and 10 = maximal pain) Secondary outcomes
Outcomes used in this review at 3 months
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Notes |
Funding: no information on funding was provided in this article Trial registration: not reported Adverse events: unclear if measured; not reported Knee surgery (replacement or osteotomy): not reported Progression of knee OA: not reported Withdrawals: unclear; pilot study results published in conference abstract (Osteras 2011, secondary publication of Osteras 2012) includes more participants Conference abstract (n = 22 participants); not reported if same participants as in Osteras 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information on sequence generation process provided |
Allocation concealment (selection bias) | Unclear risk | "The randomisation procedure was concealed from the experimenters and treating physiotherapist". There was no information on how the allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The interventionists were blinded to the group assignment; however, participants were unable to be blinded due to the nature of the intervention (surgery versus physiotherapy). |
Blinding of outcome assessor Self‐reported outcomes | High risk | Participants were not blinded and there is risk of bias in the measurement of pain, other symptoms, activities of daily living, functioning in sport and recreation, knee‐related quality of life, depression and anxiety. |
Blinding of outcome assessor Assessor‐reported outcome (knee replacement) | High risk | As the outcome assessor was not blinded to the intervention group assignment, there is risk of bias in the measurement of the quadriceps muscle strength tests. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Different numbers of participants were included in two reports (n = 17 versus n = 22). These are likely to be from a single study (trial registration not reported). |
Selective reporting (reporting bias) | Unclear risk | Trial registration not done. While outcomes described in methods were reported in the results of the main publication, there is a discrepancy in participant numbers across two reports so the risk of bias is unclear. |
Other bias | Unclear risk | Unclear if there was an unplanned interim analysis performed |