Nouraei 2011.
Study characteristics | ||
Methods | RCT, parallel design, 2‐armed trial | |
Participants |
Total number of randomised participants: 72 Source population: single centre, Iran Inclusion criteria: displaced intra‐articular fracture. States in text that 11 participants had bilateral fracture, but no description about allocation to intervention Exclusion criteria: states that "reasons that patients were not selected for surgery were as follows: participant disagreement with surgery, open fractures (not suitable for open reduction internal fixation), combined injuries (head trauma, cardiovascular disorders, severe osteoporosis...), also severe comminution" Overall baseline characteristics
Baseline characteristics for surgical group (for participants included in analysis)
Baseline characteristics for non‐surgical group (for participants included in analysis)
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Interventions |
Surgical group
Non‐surgical group
*Total number randomised is 72. However, 11 participants were lost to follow‐up, and the groups to which they originally had been allocated are unknown. |
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Outcomes |
Timing of assessments: clinical examination at 2 weeks, 1, 3, 6 months, and 1 year. Questionnaire follow‐up at 6 months Outcomes reported in this review: pain on walking (n,%), ability to wear footwear, complications. Study authors state that function was recorded using Kerr‐Atkins score, but results for this outcome were not reported. Other outcomes: swelling, limitation of activity, RoM, osteoarthritis, patient satisfaction |
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Notes |
Study dates: December 1998 and January 2009 Funding sources: not reported Declarations of interest: "authors have no conflict of interests" Notes: study authors were contacted for further information, but no reply was received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No details provided. States that "consecutive participants were randomly allocated to surgical and non surgical groups". We noted that participants were excluded from the surgical group if they had comminuted fractures, but these fracture types were not excluded from the non‐surgical group (4 of 30 participants in the non‐surgical group had comminuted fractures). We judged this to indicate possible manipulation of the randomisation method. |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to nature of intervention, treating surgeons and participants were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participant‐reported outcomes were collected by questionnaire at 6 months, and participants were aware of their treatment allocation. No information given on clinical outcome data collection or interpretation of x‐rays, and we assumed that no blinding took place |
Incomplete outcome data (attrition bias) All outcomes | High risk | 11 (15%) participants dropped after hospital discharge but these are reported as exclusions not as losses to follow‐up. Actual number randomised to each intervention arm is not reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol or clinical trials registration. It is not feasible to effectively assess risk of selective reporting bias without these documents. Patient satisfaction is included as an outcome in the Methods section but is not reported in the Results section of the study report. |
Other bias | Low risk | We identified no other sources of bias |