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Long-term results after implantation of a Reaxon Nerve Guide® to protect the nerve suture after a traumatic nerve lesion in the hand

Long-term results after implantation of a Reaxon Nerve Guide® to protect the nerve suture after a traumatic nerve lesion in the hand

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025466
Enrollment
128
Registered
2021-07-16
Start date
2021-08-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S64.4 S64.3

Interventions

Group 1: Treatment of traumatic hand nerve lesions with a Reaxon Nerve Tube in addition to the epineural suture (intervention group) Group 2: Treatment of traumatic nerve lesions with an epineural sut

Sponsors

BG Klinik Ludwigshafen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 67 Years

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Resorption state of the Reaxon Nerve Guide after treatment of traumatic hand nerve lesions

Secondary

MeasureTime frame
Regenerative potential of nerves treated with a Reaxon Nerve Guide in terms of clinical (functional) and morphological (MR Neurography and neurosonography) outcomes

Countries

Germany

Contacts

Public ContactArne Böcker

Bg Klinik Ludwigshafen

arnehendrik.boecker@bgu-ludwigshafen.de0621 6810-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026