Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial
Condition: Peripheral Nerve Injury Digital Nerve Hand Left
MeSH terms: Peripheral Nerve Injuries
Study type: Observational

Summary: 
      1. To analyse the outcome of different treatment options of peripheral nerve repair with no
           gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize
           peripheral nerve repair

        2. To reduce morbidity with the same outcome
    

Detailed description: 
      Patients planned to undergo peripheral nerve repair after traumatic nerve injury with either
      no gap (group 1) or with a critical sized defect (>5mm, group 2) of the finger providing
      written informed consent to this investigation will be randomised in two groups:.

      Group 1: nerve repair with no gap Group 1a (standard): Epineural Suture Group 1b
      (experimental): Epineural Suture and Fibrin Wrap Group 2: Nerve repair with a critical sized
      (>5mm) defect Group 2a (standard): Epineural suture and autologous nerve transplantation from
      lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and
      Fibrin Conduit

      In all groups an epineural suture will be performed (suture enhancement). The outcome of
      fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to
      date (direct nerve repair and autologous nerve graft, respectively). Randomization will be
      performed using a computer-base algorithm (www.randomizer.at). Ambulatory follow up of
      patients is carried out by the Department of Plastic, Reconstructive and Aesthetic Surgery,
      Handsurgery, University Hospital Basel. The outcome-assessor as well as the patient will be
      blinded for analysis and the outcome-assessor will have no access to the surgery report.

      The investigator's aim is to analyse 48 patients within 12 months. Since 100 patients undergo
      peripheral nerve repair annually in the Department of Plastic, Reconstructive and Aesthetic
      Surgery, Handsurgery at the University Hospital Basel, patient accrual appears unproblematic.

      After completion, statistical analysis focusing on the comparison of the different types of
      surgery concerning the clinical parameters 2-Point Discrimination (PD), Semmes Weinstein
      test, and electroneurography will be conducted.

      After six months, no difference will be expected between group 1a and 1b or 2a and 2b,
      respectively. In the investigator's experience there will be no confounders which may
      influence nerve regeneration. A similar patient satisfaction will be expected between the
      groups. The investigator expect a higher patient satisfaction in group 2b than in group 2a
      due to nerve tissue harvest. Between group 1a and 1b no difference is expected regarding MHQ.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with
        peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery,
        Handsurgery, University Hospital of Basel Written informed consent