Adams 2001.
| Study characteristics | ||
| Methods | RCT; parallel design Review comparison group: Gamma nail versus SHS |
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| Participants |
Total number of randomised participants: 400 Inclusion criteria: diagnosis of intertrochanteric fractured femur Exclusion criteria: inability to give informed consent, too frail for any operative intervention, and residence outside the region of the hospital because of the difficulty of follow‐up Setting: single centre; orthopaedic hospital, UK Intervention group 1 (Gamma nail)
Intervention group 2 (DHS)
Note:
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| Interventions |
General details: study authors report that surgeons were experienced with both implants; both groups received standard 3‐dose IV cefuroxime and routine antithrombotic prophylaxis; clinical follow‐up for 1 year or until death (3 months, 6 months, 12 months) Intervention group 1
Intervention group 2
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| Outcomes |
Outcomes measured/reported by study authors: length of surgery; operative blood loss; postoperative haemoglobin; tip‐apex distance; number of participants transfused; operative fracture of the femur; later fracture of the femur; cut‐out of implant; detachment of the plate from the femur; re‐operation; deep wound infection; superficial wound infection; DVT; mortality; use of walking aids; place of residence at follow‐up; HHS (available at 3, 6, 12 months) Outcomes relevant to the review: mortality (12 months); unplanned return to theatre (12 months) |
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| Notes |
Funding/sponsor/declarations of interest: quote: "Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received but are directed solely to a research fund, the Scottish Orthopaedic Research Trust into Trauma, a non‐profit organisation with which one or more of the authors is associated." Study dates: February 1994 to June 1995 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details |
| Allocation concealment (selection bias) | Low risk | Quotes: "At admission, patients were randomized by a closed, opaque envelope method and were assigned to receive either..." Confirmed by Adams in 2001 that "the opaque envelopes were sequentially numbered" ‐ and that there was concealment of allocation. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is not possible to blind surgeons to the type of intervention. We did not, however, expect that this would influence surgeon performance. |
| Other performance bias: surgeon experience of both implants | Low risk | Quote (from draft report): "The surgeons were experienced in the insertion of both implants". |
| Blinding of outcome assessment: mortality (detection bias) | Low risk | We did not expect that lack of blinding of outcome assessors would influence objective outcome data. |
| Blinding of outcome assessment: unplanned return to theatre (detection bias) | High risk | It is not possible to blind surgeons to treatment groups. We judged that knowledge of the type of implant could influence judgments made by surgeons when assessing subjective outcomes. |
| Blinding of outcome assessment: HRQoL (detection bias) | Low risk | Quote: "Observed‐blinded functional assessments were carried out by the unit research physiotherapist, by use of the Harris hip score." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Most losses were explained by death, which is expected in this population, and losses were reasonably balanced between groups. |
| Selective reporting (reporting bias) | Unclear risk | Study authors do not report details of pre‐published protocol or clinical trial registration. It is not feasible to effectively assess risk of reporting bias without these documents. |
| Other bias | Low risk | We identified no other sources of bias. |