| Methods |
Randomisation initially involved use of an open, predetermined randomisation chart and then was changed to "strict" alternation
Assessor blinding: none; independent assessment of quality of reduction
Intention‐to‐treat analysis: yes, though data from one participant who withdrew immediately post‐randomisation were excluded and the numbers of participants in each group at long‐term follow‐up were not reported
Loss to follow‐up: 10 (11%) of 93 in trial. |
| Participants |
Queen Mary Hospital, University of Hong Kong, Hong Kong, China
29 participants (subgroup of 93 participants with forearm fractures): 26 male (90%), mean age 35 years, range 13‐79 years. Open (3) and closed fractures: (21); 72% from low energy trauma.
Inclusion criteria: acute forearm shaft fracture in patients over 10 years old.
Exclusion criteria: pathological fracture, rheumatoid arthritis, history of long‐term steroid therapy, judged unlikely to complete follow‐up, no consent. |
| Interventions |
No details of when surgery occurred except that it was performed after randomisation. All participants were admitted into hospital and received a single injection of antibiotic. Reduction mainly done via direct fracture manipulation ‐ a distraction device was used in some cases. Both implants were titanium.
1. Point contact fixator (PC‐Fix) ‐ screws lock into screw‐hole on plate and do not enter the cortical bone on the other side of the bone
2. Limited contact dynamic compression plate (LC‐DCP) ‐ screws cross through the bone to the other side from the plate and lock into bone rather than the plate
Allocated: 17/12
Assessed: 17/12 (12 months) |
| Outcomes |
Length of follow‐up: (for whole trial population) mean 22 months (14‐40 months) but also 2, 4 and 12 months
Fracture union (radiographic)
Pain (with and without load bearing)
Complications: infection, compartment syndrome, nerve injury (0), refracture on removal of implant (0), screw pull out (0)
Range of motion (wrist and forearm)
Anatomic reduction
Length of operation
Ease of fixation |
| Notes |
Separate data for participants with isolated ulnar fracture obtained from trial investigators. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
"For the initial thirty‐two cases, an open, predetermined randomization chart was used. The chart was constructed of blocks containing four allocations. For the subsequent cases, the choice of fixation was determined in a strictly alternating fashion." Hence, quasi‐randomised. |
| Allocation concealment (selection bias) |
High risk |
As above: "open" list and then alternation. Hence no concealment of allocation. |
| Blinding (performance bias and detection bias)
Patient‐rated outcomes |
Unclear risk |
No mention of blinding. |
| Blinding (performance bias and detection bias)
Clinician‐rated outcomes |
Unclear risk |
No mention of blinding. Independent observer for judging anatomical reduction. |
| Incomplete outcome data (attrition bias)
Patient‐rated outcomes |
Unclear risk |
Only pain assessed. Inadequate information but all participants appear to have been followed up. |
| Incomplete outcome data (attrition bias)
Clinician‐rated outcomes |
Unclear risk |
Inadequate information but all participants appear to have been followed up |
| Selective reporting (reporting bias) |
Unclear risk |
Reports on typical set of outcomes for these fractures. |
| Selection bias (baseline imbalances)? |
Unclear risk |
Data provided for isolated ulnar fractures indicated a reasonable balance. |
| Performance bias (care programme discrepancies)? |
Unclear risk |
Incomplete information. Both surgeons were experienced with the devices. Slight difference in use of open reduction: 83% versus 93% for overall population. Similar follow‐up times. |
