Lundborg 2004.
Study characteristics | ||
Methods | Study type: RCT Follow‐up: 60 months |
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Participants | Participants: 30 participants (17 intervention, 13 control) Injury: < 48 hours following injury, complete transection of the median or ulnar nerve at wrist or distal forearm (< 10 cm from the wrist) Age range (years): 12–72 Sex: 4 female, 26 male |
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Interventions | Intervention: silicone tube (17 nerve repairs in 17 participants) Control: epineural end‐to‐end suturing (13 nerve repairs in 13 participants) |
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Outcomes | Outcomes measured at 3, 6, 12, 24, 36, 48, and 60 months BMRC grading for sensory recovery Sensory and motor neurophysiology RMI |
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Funding | Supported by grants from the Swedish Research Council, Swedish Brain Foundation, Faculty of Medicine, Lund University | |
Conflicts of interest | Did not state any conflict of interest. | |
Notes | 17 participants underwent neurophysiological assessment. We requested raw data, which was provided and facilitated meta‐analysis at the 24‐month time point. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Concealment was performed with sealed envelopes. It is uncertain at what point this was opened; however, all surgeries were performed within the first 48 hours following injury. |
Random sequence generation (selection bias) | Unclear risk | Detail of sequence generation not provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is unclear if participants were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The examiner was actively blinded during the first follow‐up year; however, due to small‐study size and close follow‐up, blinding was broken by 5‐year follow‐up. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 2/30 participants failed to make the 5‐year follow‐up, 1 from the conduit repair and 1 from the standard repair group. All analysis was performed as intention‐to‐treat and there were no deviations from random allocation. |
Selective reporting (reporting bias) | Low risk | Results for all expected outcomes were reported. |
Other bias | Low risk | No other specific areas of risk of bias. |