Angadi 2022.
Study characteristics | ||
Methods | RCT | |
Participants |
Country of study: India Sample size: 20 participants with 20 fractures Age: not stated Sex: not stated Fracture type: acute, closed, unstable tibial plateau fractures (Schatzker types II to VI). Type II (3 participants), type IV (3 participants), type V (6 participants), and type VI (8 participants). Injury severity: not reported Inclusion criteria: acute, closed, unstable tibial plateau fractures (Schatzker types II through VI) that required open reduction and internal fixation. Exclusion criteria: open fractures; pathological fractures; paediatric fractures; polytrauma patients. |
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Interventions |
Surgical procedure: open reduction interval fixation with standard buttress or locking plates. No further details on operative or postoperative management were provided. Technique 1 (n = 12): Bone grafts were harvested from the patient's own iliac crest. No further details were provided. Technique 2 (n = 8): tricalcium phosphate ‐ chrons granules (Synthes). No further details were provided. |
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Outcomes |
Follow‐up: 3, 6, and 12 months postoperatively Outcome measures: standard X‐ray assessment (fracture union, articular subsidence, loss or premature resorption of the graft); knee range of motion. |
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Notes | The report did not distinguish between primary and secondary outcomes. Source of funding: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation occurred: "Computerized Randomization for the type of grafting of the subarticular defect was done at the time of surgery" (Page 275). |
Allocation concealment (selection bias) | Low risk | Computer randomisation used to conceal allocation: "Computerized Randomization for the type of grafting of the subarticular defect was done at the time of surgery" (Page 275). No information on where and by whom randomisation was undertaken. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of blinding participants or personnel. Whilst it would have been logistically challenging to blind personnel to the group procedure, participants may have been practically blinded to their group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of blinding of outcome assessment. This could have been implemented in this study design. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all participants was provided at end of follow‐up (Table 2, Page 276) indicating no loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | All outcomes specified in the methods section were reported in the results section. No published protocol or trial registration number available. |
Other bias | Unclear risk | Demographic data not provided; the publication only mentions that "age, weight, height and sex of the patients and the fracture patterns were comparable in the two groups" (Page 275). There is therefore a risk of baseline imbalance between the groups and challenges in assessing the external validity of this trial. |