Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation
NCT ID: NCT06840262
Last Updated: 2025-09-05
Study Results
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.
RECRUITING
NA
45 participants
INTERVENTIONAL
2020-08-10
2027-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain
NCT05344261
Surgical Treatments for Neuroma Pain in Amputees
NCT04204668
Patient Reported Outcomes Following Targeted Muscle Reinnervation
NCT04658368
Targeted Muscle Reinnervation Study (TMR)
NCT05408520
Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in Major Limb Amputation
NCT02316262
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Determine the relative effectiveness of three surgical techniques, TMR, RPNI, and TMR with RPNI, on chronic and phantom limb pain in the oncologic amputee using the validated Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Behavior, Intensity, Interference, and Global Health Forms.
SECONDARY OBJECTIVES:
I. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques.
II. To estimate the rate of prosthetic use among oncologic amputees. III. To compare NRS and PROMIS among three surgical techniques to calculate the effect size and project the sample size which will be used to plan a multi-institutional study.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM 1: Patients undergo TMR procedure.
ARM 2: Patients undergo RPNI procedure.
ARM 3: Patients undergo TMR in combination with RPNI.
After completion of study procedure, patients are followed up at 3, 6, and 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 (targeted muscle reinnervation)
Patients undergo TMR procedure.
Questionnaire Administration
Ancillary studies
Targeted Muscle Reinnervation
Undergo targeted muscle reinnervation
Arm 2 (regenerative peripheral nerve interface)
Patients undergo RPNI procedure.
Questionnaire Administration
Ancillary studies
Regenerative Peripheral Nerve Interface Surgery
Undergo regenerative peripheral nerve interface surgery
Arm 3 (TMI + RPNI)
Patients undergo TMR in combination with RPNI.
Questionnaire Administration
Ancillary studies
Regenerative Peripheral Nerve Interface Surgery
Undergo regenerative peripheral nerve interface surgery
Targeted Muscle Reinnervation
Undergo targeted muscle reinnervation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire Administration
Ancillary studies
Regenerative Peripheral Nerve Interface Surgery
Undergo regenerative peripheral nerve interface surgery
Targeted Muscle Reinnervation
Undergo targeted muscle reinnervation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
* Patients able to complete informed consent
Exclusion Criteria
* Patients unable to give consent
* Patients receiving an amputation for non-oncologic purposes
* Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect
* Patients with multiple limb amputations
* Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Margaret S Roubaud
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
M.D. Anderson Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2021-08488
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0971
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.