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NCT Number: NCT07615465

An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission

The purpose of the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space control, and embodiment.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Transfemoral Amputation

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1 Male or Female age 22-65 at the time of surgery.
  • 2 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.

Treatment and study plan

MIT Powered Knee Prosthesis

Device

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Primary outcomes

  1. Kinematic Measures of Lower-Limb Biomechanics

    Time frame: An average of 2 sessions in the span of 1 week

    Quantitative analysis of joint angles, during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon) and embedded prosthesis sensors.

  2. Spatiotemporal Gait Parameters

    Time frame: An average of 2 sessions in the span of 1 week

    Evaluation of stance-to-swing ratio during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.

  3. Assessment of Patient Ability to Control each Joint of the Prosthesis

    Time frame: An average of 2 sessions in the span of 1 week

    Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.

  4. Ground Reaction Forces

    Time frame: An average of 2 sessions in the span of 1 week

    Quantitative analysis of ground reaction forces during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using instrumented force plates.

  5. Joint Torques

    Time frame: An average of 2 sessions in the span of 1 week

    Quantitative analysis of joint torques during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors.

  6. Walking speed

    Time frame: An average of 2 sessions in the span of 1 week

    Evaluation of walking speed during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Collaborators

  • Integrum

Registry information

Official study title

An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission - IDE Required

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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