Pain After Proximal Digital Amputation Prevention

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04378062

Acronym

PAPDAP

Enrollment

Registered

2020-05-07

Start date

2020-03-01

Completion date

2023-02-01

Last updated

2023-08-30

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

Conditions

Amputation, Amputation Neuroma, Pain

Keywords

Pain, Amputation Neuroma, Finger Amputation

Brief 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).

Detailed 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.

Interventions

PROCEDUREDigital nerve procedure

The type of procedure performed on the digital nerve at the time of amputation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
bMHQ	3 months postop minus preop; 6 months postop minus preop	Breif Michigan Hand Questionnaire Score difference

Secondary

Measure	Time frame	Description
NPS	3 months postop minus preop; 6 months postop minus preop	Numerical Pain Score difference
Grip strength	3 months postop minus preop; 6 months postop minus preop	Grip strength score difference

Other

Measure	Time frame	Description
Tinel's sign	Tinel's sign at 3 months; Tinel's sign at 6 months	Tinel's sign at amputation site

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026