Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital, Basel, Switzerland.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01573650
First received: April 5, 2012
Last updated: April 10, 2012
Last verified: April 2012
  Purpose
  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

Condition
Peripheral Nerve Injury Digital Nerve Hand Left

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Estimated Enrollment: 48
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
group 1
Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural suture and Fibrin Wrap
group 2
Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years
  • Age > 90 years
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573650

Contacts
Contact: Daniel Kalbermatten, MD, PhD 0041615565360 daniel.kalbermatten@bluewin.ch

Locations
Switzerland
University Hospital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Daniel Kalbermatten, MD, PhD    0041615565360    daniel.kalbermatten@bluewin.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Kalbermatten, MD, PhD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01573650     History of Changes
Other Study ID Numbers: Version 2, 01/04/2012
Study First Received: April 5, 2012
Last Updated: April 10, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 14, 2014