Domain	Consider whether there was a risk of:	Author’s risk of bias judgement (Low/ Unclear/ High)	Support for judgement (Quote / Comment)	Notes
Random sequence generation (selection bias)	Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.			Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Allocation concealment (selection bias)	Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment.			Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. In particular this might apply where blocked randomisation is used in that the balancing of assignment within blocks could result in some prediction of sequence.
Blinding of participants and personnel (performance bias) Subjective outcomes: e.g. Limb function and HRQoL using PROMs, physical function, pain	Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.			Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Blinding of participants and personnel (performance bias) Objective outcomes: e.g. deep SSI, amputation, unplanned operations, flap failure, wound infection, wound dehiscence, primary wound related infections, thromboembolic events, pressure sores	Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.			As above
Blinding of outcome assessment (detection bias) Subjective outcomes: e.g. Limb function and HRQoL using PROMs, physical function, pain	Detection bias due to knowledge of the allocated interventions by outcome assessors.			Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Blinding of outcome assessment (detection bias) Objective outcomes: e.g. deep SSI, amputation, unplanned operations, flap failure, wound infection, wound dehiscence, primary wound related infections, thromboembolic events, pressure sores	Detection bias due to knowledge of the allocated interventions by outcome assessors.			As above
Incomplete outcome data (attrition bias) Subjective outcomes: e.g. Limb function and HRQoL using PROMs, physical function, pain	Attrition bias due to amount, nature or handling of incomplete outcome data.			Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomised participants), reasons for attrition/exclusions where reported, and any re‐inclusions in analyses performed by the review authors.
Incomplete outcome data (attrition bias) Objective outcomes: e.g. deep SSI, amputation, unplanned operations, flap failure, wound infection, wound dehiscence, primary wound related infections, thromboembolic events, pressure sores	Attrition bias due to amount, nature or handling of incomplete outcome data.			As above
Selective reporting (reporting bias)	Reporting bias due to selective outcome reporting.			We will record if the study was prospectively registered with a trial registry and whether there was a prospectively published protocol. Where a trial registry entry or protocol was available prospectively we will compare the planned outcome reporting with the final trial report.
Other bias (bias from major imbalance in baseline characteristics) Imbalance in confounders at entry: major differences in baseline characteristics (the principal confounders considered include age, gender, type of fracture, type of prior treatment)	Bias due to major imbalance in key baseline characteristics.			Only note or consider major and inexplicable baseline imbalance that is sufficient to lead to important confounding such as exaggeration of effect estimates.
Other bias (other performance bias) Performance bias: for instance, provision of other interventions that should be comparable in both groups; or clear differences in personal characteristics of lead clinicians.	Bias due to the provision of other interventions that should be comparable in both groups; or clear differences in personal characteristics of lead clinicians.			This is incompletely covered in the ‘blinding (performance bias)’. Describe the measures taken to avoid performance bias, such as comparable training in the interventions.