Pain After Proximal Digital Amputation Prevention

Pain Clinical Trial

— PAPDAP  

Official title:

Pain After Proximal Digital Amputation Prevention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04378062
• Other study ID #: 1907889836
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).

Description:

Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).

• Patients have the capacity to complete the informed consent process

Exclusion Criteria:

• Patients less than 18 years of age, prisoner, or other vulnerable population

• Patients with significant concomitant ipsilateral extremity injuries that would confound study

• Patients requiring emergent, staged (guillotine-type) amputations of any kind

Related Conditions & MeSH terms

• Amputation
• Amputation Neuroma
• Neuroma
• Pain

Intervention

Procedure:
• Digital nerve procedure
The type of procedure performed on the digital nerve at the time of amputation

Locations

Country	Name	City	State
United States	Eskenazi Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	American Society for Surgery of the Hand

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tinel's sign	Tinel's sign at amputation site	Tinel's sign at 3 months; Tinel's sign at 6 months
Primary	bMHQ	Breif Michigan Hand Questionnaire Score difference	3 months postop minus preop; 6 months postop minus preop
Secondary	NPS	Numerical Pain Score difference	3 months postop minus preop; 6 months postop minus preop
Secondary	Grip strength	Grip strength score difference	3 months postop minus preop; 6 months postop minus preop