ong-term results after implantation of a Reaxon Nerve Guide® to protect the nerve suture after a traumatic nerve lesion in the hand
- Conditions
- S64.4S64.3Injury of digital nerve of thumbInjury of digital nerve of other finger
- Registration Number
- DRKS00025466
- Lead Sponsor
- BG Klinik Ludwigshafen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
Traumatic transection of one or more finger or thumb nerves distal to the carpal canal with autonomic sensitive innervation areas at the fingertips or thumb tips at 12 months postoperatively at the earliest.
- The nerve injury was treated by an end-to-end suture
- Either epineural nerve suture only (control group study arm 2) or nerve suture with additional use of a Reaxon Nerve Guide® (patient group study arms 1 and 2) was performed
- Injury was treated within 72 h
- Patient age was between 18 and 67 years at the time of nerve injury
- Nerve injuries that required a nerve graft for treatment
- Multiple nerve injuries that did not uniformly meet all inclusion and exclusion criteria.
- amputation injuries or injuries with risk of blood circulation due to lesion of both vessels in a finger or thumb
- time interval to surgical treatment less than one year
- ongoing immunosuppressive or antineoplastic therapy
- Patients with active autoimmune or neoplastic disease that may require immunosuppressive or antineoplastic therapy during the study period
- Lack of compliance, language barrier
- Patients not suited for MR
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resorption state of the Reaxon Nerve Guide after treatment of traumatic hand nerve lesions
- Secondary Outcome Measures
Name Time Method Regenerative potential of nerves treated with a Reaxon Nerve Guide in terms of clinical (functional) and morphological (MR Neurography and neurosonography) outcomes