Xu 2015.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: Department of Orthopedics, Central People's Hospital of Huizhou City, China Size: 78 participants; 39 in LISS group, 39 in condylar plate group Recruitment period: March 2009 to January 2013 Baseline characteristics: 54 male, 24 female; mean age: 55.6 (SD 4.2) years in LISS group, 54.9 (SD 4.0) years in condylar plate group; fractures included were AO type C1 (36 fractures), C2 (26 fractures), C3 (16 fractures) Inclusion criteria: aged ≥ 18 years; LISS plate or condylar plate selected for internal fixation; fresh fractures; informed consent signed, which was approved by the hospital ethics committee. Exclusion criteria: diseases of the heart, liver, kidney and other important organs; osteoporosis; autoimmune diseases; congenital malformation or disability of both lower limbs; contraindications for internal fixation |
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Interventions | Participant were randomised to:
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Outcomes | Schedule: mean follow‐up 12.2 (SD 2.9) months in LISS group, mean follow‐up 12.5 (SD 3.1) months in condylar plate method group Outcomes: mean operating time, length of stay, incision length, Evanich score, superficial infection, haematoma formation and implant loosening |
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Notes | Paper was translated to English to enable data extraction and review. Funding/sponsor/declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by random number table. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Nature of interventions meant that operating surgeons were not blinded. No details relating to participant blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed follow‐up, all included in the results analysis, and no dropouts. |
Selective reporting (reporting bias) | Unclear risk | No protocol registered. |
Other bias | Low risk | No other sources of bias. |
AO: Arbeitsgemeinschaft für Osteosynthesefragen; ASIF: Association of the Study of Internal Fixation; CT: computer tomography; DCS: dynamic condylar screw; DRI: Disability Rating Index; EQ‐5D: EuroQol‐5 Dimensions; EQ‐VAS: EuroQol‐Visual Analogue Scale; KSS: Knee Society Score; LCP: locking condylar plate; LISS: Less Invasive Stabilization System; MFA: Musculoskeletal Function Assessment; NCB: non‐contact bridging; NHS: National Health Service; OKS: Oxford Knee Score; ORIF: open reduction and internal fixation; OTA: Orthopaedic Trauma Association; PSS: Personal Social Services; RCT: randomised controlled trial; RIMN: retrograde intramedullary nail; SD: standard deviation; SF‐12: 12‐item Short Form; SF‐36: 36‐item Short Form; SMFA: Short Musculoskeletal Function Assessment; VAS: Visual Analogue Scale.