Karumo 1977.
Study characteristics | ||
Methods | Randomised trial: use of random numbers | |
Participants | University Central Hospital, Helsinki, Finland Period of study: May 1973 to October 1974 100 participants Inclusion: people aged > 50 years with femoral neck fracture treated surgically (internal fixation or prosthesis), capable of independent 'getting about' before fracture Exclusion: none given Age: mean 73 years (range not stated; all over 50 years) % male: 25% Number lost to follow‐up: 13 (excluded from 9‐week follow‐up because of inadequate follow‐up), 4 (excluded from 3‐month mortality data) | |
Interventions | Early postoperative rehabilitation, started first postoperative day onwards
1. Intensive (performed twice daily) physiotherapy regimen
versus
2. Same regimen performed once daily (conventional care) Routine physiotherapy was on average 30 minutes per day. For the intensive group, the physiotherapy time was doubled. Both groups were under supervision of the study physiotherapist. Regimen was continued for 14 days. From first postoperative day, training in walking on crutches; training in sitting in chair; flexion‐extension movements of knee, hip and ankle. Most participants were allowed full weight bearing from the beginning. (For those with internal fixation, crutch use for up to 2 to 3 months.) From second postoperative week, training in walking up and down stairs. |
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Outcomes | Length of follow‐up: 9 weeks (for strength) Walking ability Ability to move and sit up in bed on first postoperative day Abductor muscle strength at 9 weeks Residence at 9 weeks Mortality "Mechanical" postoperative complications Medical complications, including thromboembolism and postoperative infection Length of hospital stay |
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Notes | Of the 100 people recruited for the trial, 13 had inadequate follow‐up and the results of these participants are not presented. Most of the results for the trial were presented split according to whether the participant had a prosthesis or internal fixation, rather than by the trial interventions. A thesis (1978, University of Helsinki) was located by Lesley Gillespie (10 June 2004). Requests for a copy met with no success. Funding: none declared Conflict of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Using random numbers the patients selected for the study were divided before the operation into two physiotherapy groups." |
Allocation concealment (selection bias) | Unclear risk | No report |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding. Impact of non‐blinding is unclear |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | High risk | No mention of blinding |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | No mention of blinding; however, assessment of the outcome is unlikely to be influenced by knowledge of group allocation. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | Results for 13 participants with inadequate follow‐up were not presented. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | High risk | Results for 13 participants with inadequate follow‐up were not presented. |
Selective reporting (reporting bias) | High risk | Mobility data split by treatment group were not presented. |
Free from baseline imbalance bias? | High risk | There was a lack of information on baseline characteristics and comparability; data were not provided for 13 participants with inadequate follow‐up. The report referred to a non‐significantly greater number of participants in the routine physiotherapy group being treated with Jewett nails. |
Free from performance bias due to non‐trial interventions? | Low risk | Appears so; the same physiotherapist provided both interventions. |