Pain After Proximal Digital Amputation Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

NCT05008185

Neuroma

RECRUITING

Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation

NCT02205385

Neuroma Neuroma Amputation Pain

COMPLETED NA

Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

NCT01837407

Complex Digital Injuries

COMPLETED NA

The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees

NCT05554900

Amputation Neuroma

UNKNOWN NA

The Effect of Pre-operative Electrical Stimulation on Peripheral Nerve Regeneration.

NCT03205124

Peripheral Nerve Injuries Sensory Deficit Digital Nerve Lesion

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Amputation Neuroma Amputation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traction Neurectomy

Traction neurectomy - of digital sensory nerves at the time of amputation.

Group Type ACTIVE_COMPARATOR

Digital nerve procedure

Intervention Type PROCEDURE

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

Targeted Muscle Reinnervation

Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation

Group Type EXPERIMENTAL

Digital nerve procedure

Intervention Type PROCEDURE

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

Regenerative Peripheral Nerve Interface

Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation

Group Type EXPERIMENTAL

Digital nerve procedure

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital nerve procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No