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e-OPRA Implant System for Lower Limb Amputees

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ClinicalTrials.gov Identifier: NCT03720171
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Integrum

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date January 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
Electrode function [ Time Frame: 24 months ]
i) To evaluate implantation robustness, and connector/lead integrity: i.a. Measured Impedance (kOhms) i.b. Maximal Voluntary Contraction (MVC) Amplitude (mV) ii) To evaluate sensor function and signal quality: ii.a. Signal-to-noise ratio (SNR) above 2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
Preferred walking speed [ Time Frame: 24 months ]
Preferred walking speed, as each subject ambulates with the neuromechanical prosthesis, will be evaluated. Preferred walking speed will be compared to a non-amputee height/weight match for each enrolled subject. A baseline data set will first be collected for each subject ambulating with a conventional prosthesis. Each subject will be timed as they traverse a predetermined distance at a steady speed that they deem most comfortable.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE e-OPRA Implant System for Lower Limb Amputees
Official Title  ICMJE An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations
Brief Summary

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The purpose of the study is to evaluate the feasibility of a lower limb amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system.

A maximum of six subjects will be enrolled. Each subject will undergo a surgery where the e-OPRA Implant System will be implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, non-randomized, uncontrolled study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amputation
Intervention  ICMJE Device: e-OPRA Implant System
Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis
Study Arms  ICMJE Experimental: e-OPRA Implant System
Implantation of e-OPRA Implant System in lower limb.
Intervention: Device: e-OPRA Implant System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 17, 2023
Estimated Primary Completion Date January 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A potential subject will be included in the study if she/he meets all of the following inclusion criteria:

  • Male or Female age 22-65 at the time of surgery.
  • The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and:

A: At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B: At a minimum level of amputation of 16 cm above the knee joint line as part of a single-stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.

  • The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition.
  • The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
  • The patient must have adequate bone stock to support the implanted device.
  • In the opinion of the investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
  • Written informed consent to participate in the study provided by the patient or legal representative.

Exclusion Criteria:

  • Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
  • Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
  • Active infection or dormant bacteria.
  • Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
  • Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, Neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the subject to be a good study candidate.
  • Evidence of any active skin disease involving the proposed surgical limb.
  • History of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
  • Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
  • The patient is currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hugh M Herr, PhD 617-314-3661 hherr@media.mit.edu
Contact: Matthew J Carty, MD 617-983-4555 mcarty@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03720171
Other Study ID Numbers  ICMJE IDE G170304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Integrum
Study Sponsor  ICMJE Integrum
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts Institute of Technology
Investigators  ICMJE
Principal Investigator: Hugh M Herr, PhD Massachusetts Insititute of Technology
PRS Account Integrum
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP