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. 2015 Aug 13;2015(8):CD010606. doi: 10.1002/14651858.CD010606.pub2

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
Interventions Participants were allocated to either:
  • retrograde intramedullary nail via an intercondylar notch approach. Nails were 20‐25 cm long and locked with 2 proximal screws and 2 or 3 distal screws

  • dynamic condylar screw with 95° angle plate. Primary autologous bone grafting of the medial cortex was used in 3 participants


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
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
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