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ORIGINAL ARTICLE
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Interim analysis of recruitment data for a randomized control trial of digital nerve repair


 West Midlands Peripheral Nerve Injury Service, Queen Elizabeth Hospital Birmingham, Birmingham, B15 2TH, United Kingdom

Correspondence Address:
Sunil Parthiban,
Hand and Peripheral Nerve Unit, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2TH
United Kingdom
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jmsr.jmsr_107_18

Objectives: Digital nerves provide a good model for testing efficacy of repair techniques. Injuries are often standardized, with high numbers of patients and reasonable follow-up time scales. The gold standard treatment for a complete, traumatic peripheral nerve lesion involves direct end-to-end microsurgical repair. Conduits may reduce tethered scar at repair sites and provide a supported segment for a sutureless repair. A randomized controlled trial (RCT) investigating the outcomes of digital nerve repair requires a two-stage recruitment process. Interim analysis of our study design aimed to identify the areas of improvement for recruitment efficiency. Methods: Patients with reduced sensation in a digital nerve distribution were referred to a research nurse for consent and first-stage recruitment to the Conduit Nerve approximation versus Neurorrhaphy Evaluation of Clinical outcome Trial (CoNNECT). Intraoperative confirmation of a complete nerve injury allowed second-stage recruitment and randomization. Analysis of screening data and recruitment logs from June 2017 to December 2018 enabled the assessment of recruitment efficiency. Results: We assessed 268 patients as suitable for CoNNECT with 82% consenting to take part in the trial. Eighty-five patients were deemed suitable intraoperatively; however, only 69 patients were successfully recruited. Patients were missed due to operating surgeons not being trained in the CoNNECT protocol, time constraints, and inadequate planning of theater resources. Conclusion: Key areas effecting recruitment include adequate provision of staff training workshops, prioritization of trial patients, and improved communication with patients. The results of this audit into recruitment to an RCT in digital nerve repair will help inform future studies in this area.


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    -  Parthiban S
    -  Foster MA
    -  Beale S
    -  Power DM
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