MedDataX Logo

Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

NCT ID: NCT05344261

Last Updated: 2023-12-05

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-30

Brief Summary

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

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

Detailed Description

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

The investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at Parkland Memorial Hospital. Eligible patients undergoing an amputation will be consented for all possible interventions and randomized to either receive Targeted Muscle Re-Innervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), or standard post-amputation surgical care at the time of their operation. Key pre-operative data including patient sex, age, BMI, past medical history, past surgical history, medications, allergies, social history, social support systems, exposure to narcotic medication, and reason for amputation will be analyzed. Intra-operatively, patients randomized to the treatment arm will receive TMR or RPNI and the transected nerve ends addressed will be recorded. Post-operative data that will be recorded include hospital stay, complications related to the procedure, complications leading to reoperation, functional results, need for pain medication, incidence of phantom limb pain, incidence of painful neuromas, length of follow-up, and all adverse events/complications. Analyses will be conducted using data obtained from patient medical records from the Parkland Health \& Hospital System.

Conditions

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

Amputation Neuroma Amputation Phantom Limb Pain Residual Limbs

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Targeted Muscle Re-innervation Regenerative Peripheral Nerve Interface TMR RPNI

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

SINGLE

Participants

Study Groups

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

Control Arm

Standard Post-Amputation Surgical Care: Briefly, the transected nerves will be blindly tucked into surrounding bulky soft tissue to protect the nerve ends before the wound is closed.

Group Type ACTIVE_COMPARATOR

Standard Post-Amputation Surgical Care

Intervention Type PROCEDURE

Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.

Targeted Muscle Re-innervation

Briefly, each transected nerve is identified after amputation using 6-0 Prolene suture and is dissected proximally for length. With minimal dissection, a nerve stimulator is used to identify functional motor nerve branches. Near the point where the motor branch enters the muscle, the motor nerve branch is transected and an end-to-end coaptation is performed with a nearby tagged amputated nerve.

Group Type EXPERIMENTAL

Targeted Muscle Re-innervation

Intervention Type PROCEDURE

Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.

Regenerative Peripheral Nerve Interface

Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).

Group Type EXPERIMENTAL

Regenerative Peripheral Nerve Interface

Intervention Type PROCEDURE

Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

Interventions

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

Targeted Muscle Re-innervation

Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.

Intervention Type PROCEDURE

Regenerative Peripheral Nerve Interface

Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

Intervention Type PROCEDURE

Standard Post-Amputation Surgical Care

Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site 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 ≥18 years old
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) as a primary or secondary sequela of trauma.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for primary or secondary sequelae of malignancy.
* Secondary sequalae include but is not limited to metastatic disease and osteolytic disease.
* Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for vasculitic diseases.

Exclusion Criteria

* Patients less than 18 years old
* Patients with cognitive impairment
* Patients who are imprisoned at the time of randomization
* Patients currently enrolled in other studies relating to neuropathic pain
* Patients actively undergoing radiation therapy
* Patients with existing neuroma or underwent prior neuroma surgery
* Patients with amputations scheduled congenital reasons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Travis Boyd

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah Noble

Role: STUDY_DIRECTOR

UT Southwestern Department of Plastic Surgery

References

Explore related publications, articles, or registry entries linked to this study.

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

Reference Type BACKGROUND
PMID: 18295618 (View on PubMed)

Dumanian GA, Potter BK, Mioton LM, Ko JH, Cheesborough JE, Souza JM, Ertl WJ, Tintle SM, Nanos GP, Valerio IL, Kuiken TA, Apkarian AV, Porter K, Jordan SW. Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial. Ann Surg. 2019 Aug;270(2):238-246. doi: 10.1097/SLA.0000000000003088.

Reference Type BACKGROUND
PMID: 30371518 (View on PubMed)

Valerio IL, Dumanian GA, Jordan SW, Mioton LM, Bowen JB, West JM, Porter K, Ko JH, Souza JM, Potter BK. Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation. J Am Coll Surg. 2019 Mar;228(3):217-226. doi: 10.1016/j.jamcollsurg.2018.12.015. Epub 2019 Jan 8.

Reference Type BACKGROUND
PMID: 30634038 (View on PubMed)

Eberlin KR, Ducic I. Surgical Algorithm for Neuroma Management: A Changing Treatment Paradigm. Plast Reconstr Surg Glob Open. 2018 Oct 16;6(10):e1952. doi: 10.1097/GOX.0000000000001952. eCollection 2018 Oct.

Reference Type BACKGROUND
PMID: 30534497 (View on PubMed)

Kubiak CA, Kemp SWP, Cederna PS, Kung TA. Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Plast Reconstr Surg. 2019 Sep;144(3):421e-430e. doi: 10.1097/PRS.0000000000005922.

Reference Type BACKGROUND
PMID: 31461024 (View on PubMed)

Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.

Reference Type BACKGROUND
PMID: 32115057 (View on PubMed)

Kuiken TA, Barlow AK, Hargrove L, Dumanian GA. Targeted Muscle Reinnervation for the Upper and Lower Extremity. Tech Orthop. 2017 Jun;32(2):109-116. doi: 10.1097/BTO.0000000000000194.

Reference Type BACKGROUND
PMID: 28579692 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU-2021-0348

Identifier Type: -

Identifier Source: org_study_id