Moller 1986.
Methods | Prospective, single‐centre, non‐blinded, randomised controlled trial | |
Participants | Based in Denmark. No recruitment/study dates documented We assume participants are 'mixed civilian' but this is not actually stated. Unclear who diagnosed and determined eligibility 35 participants (35 unilateral knees) (25 female, 10 male; mean age 23 years (range 18 to 35); mean duration of symptoms 21 months (3 to 120 months)) Two groups: Knee brace group: n = 17 (gender, age and duration of symptoms not specified; 10 participants had a history of patellar subluxation and 7 participants had a history of idiopathic chondromalacia patellae) Control group: n = 18 (gender, age and duration of symptoms not specified; 7 participants had a history of patellar subluxation; and 11 participants had a history of idiopathic chondromalacia patellae) Inclusion criteria: Arthroscopy was done on all knees and revealed different stages of diseased articular cartilage. The knees were initially evaluated subjectively and objectively according to the numerical rating system described by Turba 1979, assessing swelling, pain, symptoms of instability, and limitation of activity. Objectively, the evaluation included motion, pain effusion, quadriceps atrophy, and patellar hypermobility. Exclusion criteria: Patients with obvious signs of meniscus tears, joint laxity, radiological osteoarthritis, former surgery of the knee, or recurrent subluxation of the patella |
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Interventions |
Knee brace group: In addition to the exercise programme, participants in this group wore a knee brace made of orthoplast. The brace only allowed a knee range of motion from 0 to 30 degrees of flexion. The brace was worn for a 6‐week period. No details provided with regards to whether the brace was worn at night or not. Control group: An isometric quadriceps and hamstrings exercise programme. This was performed for at least 15 minutes, 4 times daily. Participants were asked to exercise within the limits of their pain. |
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Outcomes | A follow‐up was performed after 6 weeks and 3 and 12 months Outcome measures included:
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Notes | Five participants subsequently underwent surgery; 4 for correction of patellar malalignment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention of randomisation procedure. No detail provided regarding sequence generation. Patients and Methods section (page 377) “seventeen patients were randomised to a knee brace made of orthoplast”. |
Allocation concealment (selection bias) | Unclear risk | No mention of randomisation procedure, with the methods of allocation concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | This was not described in the paper. It was unclear from information presented in the paper which personnel were involved in the trial and whether they were blinded to group allocation. Given the nature of this intervention, it would be logistically difficult to blind participants or personnel to group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | There was insufficient information detailing potential assessor blinding, and data collection of the outcome measures. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All participants seem to be accounted in the Results section (page 378) but incomplete reporting of data (see next item). |
Selective reporting (reporting bias) | High risk | All outcome measures discussed in the Patients and Methods sections were presented in the Results section (page 387). However, no raw data were available and no numerical values were provided for the Turba scale. The paper only presented the frequency of 'excellent' and 'good' results as a combined number. It was therefore difficult to interpret the Results (Page 378 and Table 1). |
Other bias | High risk | The Patients and Methods section was not clear, particularly in relation to the data collection procedure, which was not described. No separate baseline characteristics (sex, age, duration of symptoms) provided. |
Outcomes in bold are those that are relevant for this review.