AmputationNCT03720171
e-OPRA Implant System for Lower Limb Amputees
A study testing e-OPRA Implant System in people with Amputation, run by Integrum at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- e-OPRA Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 8 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations
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.
- Conditions
- Amputation
- Being tested
- e-OPRA Implant System
- Keywords
- Osseointegration, Bone-anchored prosthesis, Neuro-prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-OPRA Implant SystemDevice
Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis
| Study group | Role | What they receive |
|---|---|---|
| e-OPRA Implant System | Experimental | Implantation of e-OPRA Implant System in lower limb. Receives: Device: e-OPRA Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrode function
- 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
Measured: 24 months
Secondary outcomes (1)
Preferred walking speed
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start17 Jan 2018
- Primary completion8 Mar 2025
- Study completion8 Mar 2025
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, uncontrolled study.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Hugh M Herr, PhD, Principal investigator, Massachusetts Insititute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720171
- Sponsor's protocol ID
- IDE G170304
- Status last verified
- May 2025
- First submitted
- 19 Oct 2018
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations
- ClinicalTrials.gov ID
- NCT03720171
- Acronym / sponsor ID
- IDE G170304
- Conditions
- Amputation
- Keywords
- Osseointegration, Bone-anchored prosthesis, Neuro-prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- IntegrumIndustry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Massachusetts Institute of Technology
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, uncontrolled study.
| Arm | Type | Receives |
|---|---|---|
| e-OPRA Implant System | Experimental | Device: e-OPRA Implant SystemImplantation of e-OPRA Implant System in lower limb. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-OPRA Implant SystemImplantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis | Device | e-OPRA Implant System |
Primary outcome
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
1 secondary outcome
Preferred walking speed
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh M Herr, PhD principal investigator
Massachusetts Insititute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-OPRA Implant System in people with Amputation, run by Integrum at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrode function (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.