Recruiting

Regenerative Surgery

Sponsor:

University of Michigan

Code:

NCT03260400

Conditions

Amputation Neuroma

Amputation

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

a bipolar percutaneous intramuscular electromyography electrode

Study Details

Brief summary:

The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Conditions

Amputation Neuroma

Amputation

Study ID

NCT03260400

Start date

Dec 11, 2017

Status verified date

Aug, 2026

Completion date

May 5, 2029

Anticipated

Primary completion date

May 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be 22 years of age or older.
  • Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo an upper limb amputation proximal to the wrist.
  • For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.
  • Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
  • Participants must have reliable transportation.
  • Participants must be able to attend at minimum 6 hours of experiments per month while electrodes remain implanted.
  • Participants must be at least 6 months post-amputation.
  • Participants who will receive an amputation at the same time as RPNI grafts and electrodes must be undergoing an elective amputation surgery where loss of useful function of the hand has occurred. They must be at least 6 months post-injury or failed limb salvage to participate.

Exclusion Criteria:

  • Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
  • Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
  • Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
  • Participants must not have used tobacco for at least one month prior to enrollment in the study.
  • Participants must agree to not use tobacco for the duration of the study.
  • Participants cannot have sustained bilateral upper extremity amputation.
  • Participants cannot be pregnant.
  • Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
  • Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
  • Participants must not have an autoimmune condition which is not well controlled by medication.
  • Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: New Grafts

In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin.

experimental: Existing Grafts

In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin.

Interventions

a bipolar percutaneous intramuscular electromyography electrode

The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Primary outcome measure

  • Change in Pain Level as measured by SF-36 [ Time Frame: Baseline and monthly for up to 10 years postoperatively ]
  • Change in Pain Level as measured by LANSS survey [ Time Frame: Baseline and monthly for up to 10 years postoperatively ]
  • Change in Pain Level as measured by Phantom Limb Questionnaire [ Time Frame: Baseline and monthly for up to 10 years postoperatively ]
  • RPNI tissue degeneration measured by pain scores [ Time Frame: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted. ]
  • RPNI electrode migration assessed by changes recording in efficacy and ultrasound [ Time Frame: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted. ]

Central Contacts and Locations

Central contacts

Paul Cederna, M.D.

734-936-5885cederna@umich.edu

Karunakar Uppalapati, MS

517-356-3782karunaka@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

University of Michigan

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • RPNI
  • Regenerative Peripheral Nerve Interface

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-18.