Hanschen 2014.
Study characteristics | ||
Methods | Prospective RCT | |
Participants | Setting: 4 university trauma centres in South Germany Size: 27 participants; 12 to LISS group, 15 to NCB group) Recruitment period: 2008–2011 Baseline characteristics: 8 males, 19 females; mean age 63.9 years in LISS group, 73.1 years in NCB group; fractures included were AO/OTA type A (11 fractures), B (3 fractures), C (7 fractures); 6 periprosthetic fractures and 5 open fractures. Inclusion criteria: fractures of distal femur; all type 33‐A (11), 33‐B (3) and 33‐C (7) fractures were included, as well as periprosthetic fractures of the distal femur. Exclusion criteria: none listed |
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Interventions | Either a standardised antero‐lateral or additional medial approach used to reduce fragments. Temporary fixation achieved using K‐wires, screws or clamps. Locking plate then applied with temporary K‐wire fixation. Plate then fixed. Participants randomised to:
All participants received prophylactic antibiotics. Physiotherapy commenced postoperatively with range of motion exercises. Participants instructed to be non‐weight‐bearing for 6–8 weeks. |
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Outcomes | Schedule: 1 and 6 weeks; 3, 6, 9 and 12 months Outcomes: mean operating time, mean intraoperative x‐ray time, mean skin cut length, need for skin cut extension, mean size of implant, intraoperative arthroscopy, surgical complication (wound infection, peroneal lesions, compartment syndrome), range of motion, cruciate ligament stability, collateral ligament stability, VAS, OKS, Rasmussen score, Lysholm score, Tegner score |
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Notes | Funding/sponsor/declarations of interest: study author instructor for a course provided by 1 of the companies producing implants. No information provided on funding or sponsors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised according to a randomisation plan (Randlist). To ensure balanced randomisation in all 4 trauma centres, randomisation performed blockwise. |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Nature of interventions meant that the operating surgeons were not blinded. No details relating to participant blinding. All surgeons described as experienced. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers of participants with data for each variable not reported, though no reporting of missing data. |
Selective reporting (reporting bias) | Unclear risk | No study prospectively published protocol or registration exists. |
Other bias | Low risk | We identified no other sources of bias. |