AmputationNCT06840262
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
A study testing Questionnaire Administration, Regenerative Peripheral Nerve Interface Surgery and Targeted Muscle Reinnervation in people with Amputation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates two surgical techniques (targeted muscle re-innervation [TMR] and regenerative peripheral nerve interfaces [RPNI]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Questionnaire Administration, Regenerative Peripheral Nerve Interface Surgery and Targeted Muscle Reinnervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 2 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons
- Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
- Patients able to complete informed consent
Who cannot join
- Patients under 18 years of age
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Margaret S. Roubaud, 713-794-1247, msroubaud@mdanderson.org
Margaret S. Roubaud
About this study
Official title: Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study
This clinical trial evaluates two surgical techniques (targeted muscle re-innervation [TMR] and regenerative peripheral nerve interfaces [RPNI]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.
Read the detailed description
PRIMARY OBJECTIVE:
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:
- 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
- Amputation
- Being tested
- Questionnaire Administration, Regenerative Peripheral Nerve Interface Surgery, Targeted Muscle Reinnervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Regenerative Peripheral Nerve Interface SurgeryProcedure or surgery
Also called Regenerative Peripheral Nerve Interface, RPNI
Undergo regenerative peripheral nerve interface surgery
Targeted Muscle ReinnervationProcedure or surgery
Also called TMR
Undergo targeted muscle reinnervation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (targeted muscle reinnervation) | Active comparator | Patients undergo TMR procedure. Receives: Other: Questionnaire Administration; Procedure: Targeted Muscle Reinnervation |
| Arm 2 (regenerative peripheral nerve interface) | Active comparator | Patients undergo RPNI procedure. Receives: Other: Questionnaire Administration; Procedure: Regenerative Peripheral Nerve Interface Surgery |
| Arm 3 (TMI + RPNI) | Experimental | Patients undergo TMR in combination with RPNI. Receives: Other: Questionnaire Administration; Procedure: Regenerative Peripheral Nerve Interface Surgery; Procedure: Targeted Muscle Reinnervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start10 Aug 2020
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret S Roubaud, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840262
- Sponsor's protocol ID
- 2019-0971
- Other IDs
- NCI-2021-08488
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No