Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial
- 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
- To reduce morbidity with the same outcome
Peripheral Nerve Injury Digital Nerve Hand Left
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial|
- 2-PD [ Time Frame: 2wks, 3mts and 6mts ] [ Designated as safety issue: No ]
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural suture and Fibrin Wrap
Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573650
|Contact: Daniel Kalbermatten, MD, PhDemail@example.com|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4031|
|Contact: Daniel Kalbermatten, MD, PhD 0041615565360 firstname.lastname@example.org|
|Principal Investigator:||Daniel Kalbermatten, MD, PhD||University Hospital, Basel, Switzerland|