NCT04204668: STOCAP

Surgical Treatments for Neuroma Pain in Amputees

Withdrawn NA Last updated 3 June 2025

What this trial tests

NA trial testing TMR in Pain, Neuropathic. Withdrawn.

Timeline

1 April 2021

Primary endpoint
12 February 2025

12 February 2025

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 April 2021
Primary completion	12 February 2025
Estimated completion	12 February 2025
Sites	2 locations across United States

Drugs / interventions tested

• TMR
• RPNI
• VDMT

Conditions studied

• Pain, Neuropathic — all drugs for Pain, Neuropathic →
• Amputation Neuroma — all drugs for Amputation Neuroma →
• Phantom Limb Pain — all drugs for Phantom Limb Pain →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Pain, Neuropathic or Amputation Neuroma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amputees often suffer from relentless pain and disability resulting from symptomatic neuromas within the amputation stumps. When conservative measures fail to address these symptoms, two contemporary surgical approaches to treat symptomatic neuromas have become the most popular. Targeted muscle reinnervation (TMR) is a procedure which involves transferring the injured proximal nerve stump into a terminal nerve branch entering muscle, such that the axons from the proximal nerve stump will regenerate into the muscle and thereby prevent neuroma recurrence. Regenerative peripheral nerve interfaces (RPNIs) are muscle grafts placed on the proximal nerve stumps that serve as targets for the regenerating axons from the proximal nerve stumps.

While TMR and RPNIs have demonstrated promise for the treatment of symptomatic neuromas, prospective comparative data comparing outcomes with these two approaches is lacking.

The investigators have recently developed a novel approach to treat symptomatic neuromas that provides vascularized, denervated muscle targets (VDMTs) for the axons regenerating from the severed proximal nerve stump to reinnervate. This is accomplished by islandizing a segment of muscle on its blood supply and ensuring complete denervation prior to implanting the neighboring transected nerve stump into this muscle. VDMTs offer theoretical benefits in comparison to RPNIs and TMR that the investigators also aim to test in the proposed study.

The investigators' objective is to enroll amputees with symptomatic neuromas into a prospective study in which amputees will be randomized to undergo TMR, RPNI, or VDMT and subsequently monitored for pain and disability for 1-year post-operatively. The investigators' specific aims are as follows: 1) Test the hypothesis that VDMTs are more effective than TMR and RPNIs with regards to treating pain and disability associated with symptomatic neuromas; 2) Provide the first level one, prospective data directly comparing the efficacy of TMR and RPNIs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.