Christodoulou 2005.
Methods | Quasi‐randomised controlled trial: allocation alternated between interventions after stratification by fracture type | |
Participants | Setting: Hippokratio General Hospital, Thessaloniki, Greece Size: 80 participants; 35 in the nail group and 37 in the plate group (allocation not reported in 8 participants, 5 of whom died and 3 who were lost to follow‐up) Recruitment period: January 1994 to June 1999 (2000 in abstract) Baseline characteristics: 25 men, 47 women; median age 73.2 years (range 60‐88). All fractures were closed without substantial soft tissue damage. Fracture types in the nail group were AO/ASIF A1 34%, A2 40%, A3 14%, C1 9%, C2 3%; and the plate group were A1 35%, A2 35%, A3 16%, C1 8%, C2 6%. Age, sex and other variables not reported Inclusion criteria: supracondylar fracture of the femur Exclusion criteria: not reported |
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Interventions | Participants were allocated to either:
A tourniquet and wound drainage was used for all participants. Prophylactic perioperative antibiotics and postoperative anticoagulants were used in all participants. Continuous passive motion was started on the 2nd or 3rd postoperative day and mobilisation with partial weight‐bearing on 4th or 5th day |
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Outcomes | Schedule: 6, 12, 24 and 52 weeks and annually thereafter. Mean follow‐up was 28 months (18‐42 months) Outcomes: Schatzker and Lambert criteria (full extension, loss of flexion, valgus/varus/rotational deformity, pain, and joint congruency), length of hospital stay, operation time, blood loss, radiological union, clinical union, complications, death |
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Notes | Attempt at personal communication was unsuccessful | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "allocation alternated between each intervention after stratification by AO fracture classification" Comment: quasi‐randomised |
Allocation concealment (selection bias) | High risk | The next intervention for each fracture type was known |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The nature of the interventions means that the operating surgeons were not blinded. There were no details relating to participant blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention was made of blinding of outcome assessment. Additionally, outcome assessment was poorly reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Only 10% participants were lost to follow‐up: 5 died and 3 changed address. The allocation of these participants was not reported and they were not included in the final analysis |
Selective reporting (reporting bias) | Unclear risk | No protocol was available |
Imbalance in baseline characteristics (selection bias) | Low risk | Quote: "there were no differences concerning the pre‐injury condition of the patients in both groups" Comment: in addition reported baseline fracture classifications were similar as would be expected due to stratification prior to allocation |
Care provider expertise (performance bias) | Unclear risk | Providers of interventions not stated |