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. 2024 Aug 22;2024(8):CD009679. doi: 10.1002/14651858.CD009679.pub3

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.
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.
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.
Notes The report did not distinguish between primary and secondary outcomes.
Source of funding: none reported
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.