ongitudinal observational study of the influence of selective nerve transfer on amputation-associated pai

Recruiting

• Conditions: D36.1; M79.65; M79.66; Peripheral nerves and autonomic nervous system; M79.67; M79.69

• Registration Number: DRKS00028600
• Lead Sponsor: BG Klinikum Duisburg gGmbH Klinik für Hand- & Plastische Chirurgie, Brandverletzungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Condition after transtibial / transfemoral amputation with a painfull stump neuroma and phantom limp pain or scheduled transtibial / transfemoral major amputation
• written consent

Exclusion Criteria

• Dysmelia
• Amputation by the reason of peripheral arterial disease
• Minor amputation of the lower extremity
• Bilateral or threefold / fourfold amputation of extremities
• Neurological cognitive comorbilities
• Insufficient knowledge of the german language
• Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of amputation-specific pain after selective nerve transfer at patients with an amputated leg measured by a numeric rating scale (NRS) before surgery and 6, 12, 24 and 36 month post surgery.

Secondary Outcome Measures

Name	Time	Method
• Pain measured by questionnaires (von KORFF, DASS, Pain Detect, PDI, Pain Detect, PCS) before surgery and 6, 12, 24 and 36 month after surgery.<br>• Health related quality of life measured by questionnaires (EQ-5D, PHQ-2) before surgery and 6, 12, 24 and 36 month after surgery.<br>• Mobility and occupational inclusion measured by functional parameters and the PLUS-M questionnaire 6 and 12 month after surgery.<br>