Upper Limb AmputationOHMGNCT03178890
Osseointegrated Human-Machine Gateway
A study testing OHMG in people with Upper Limb Amputation, run by Integrum at 1 site in Sweden.
Trial summary
Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Upper Limb Amputation
- What is being tested?
- OHMG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 26 Sep 2016to 30 May 2024
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is an uni- or bi-lateral, transhumeral or transradial amputee
- At least 2 cm from the joint to the most proximal side of the fixture must be present.
- The patient has at least portion of biceps and triceps muscles present.
- The patient currently has, or has been accepted to have, the OPRA Implant System.
- The patient is younger than 70 and older than 17.
- The patient is willing to participate in all assessment sessions (follow-ups).
- The patient has experience using a surface myoelectric prosthesis.
Who cannot join
- Patient that has a significant cognitive impairment that prevents her/him from following instructions.
- The patient has any concurrent disease or conditions that might affect the treatment with the OHMG.
- The patient is pregnant.
- The patient is participating in another study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Paolo Sassu, MD, paolo.sassu@vgregion.se
About this study
Official title: The Osseointegrated Human-machine Gateway
Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin. This way of recordings is often unreliable, inconsistent and leading to high prosthetic abandonment rates for individuals with upper limb amputation. The use of implantable electrodes has been long thought as the solution for a more natural control of artificial limbs, as these offer access to long-term stable and physiologically appropriate sources of control, as well as the possibility to elicit appropriate sensory feedback via neurostimulation.
This Clinical Investigation (CI) is performed to clinically test and verify the safety and benefits of 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 artificial limbs. The bidirectional interface is based, and requires, the clinically established implant system for bone-anchored prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The feasibility of the device was initially proven through a proof-on-concept patient who has used the system without any adverse events for more than three years.
This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb amputation, when used within the intended purpose and according to instructions. The CI will be performed at Sahlgrenska University Hospital and Chalmers University of Technology, Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the last one approximately 13 months after the surgery. The study is prospective, where the patient is his/her own control.
- Conditions
- Upper Limb Amputation
- Being tested
- OHMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHMGDevice
Device will be implanted in all enrolled patients.
| Study group | Role | What they receive |
|---|---|---|
| Osseointegrated Human Machine Gateway (OHMG) | Experimental | Patients will be upgraded to the OHMG if already users of the OPRA Implant System, or implanted with the OPRA Implant System plus OHMG. Each patient will work as his/her own control before and after implantation of the OHMG.
A single surgery is required to upgrade OPRA Implant System users to the OHMG, and no additional surgeries are required if the OHMG is implanted at the same time as the OPRA Implant System. Receives: Device: OHMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total study population with Adverse Events graded as Serious Adverse Events (SAE)
Serious adverse events are characterized as a) led to death b) led to serious deterioration in health of the subject, that either results in (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or body function, (iii) in-patient or prolonged hospitalization, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.
Measured: 13 months
Number of subjects with at least two independent myoelectric signals, and at least one sensory feedback location
For a case to be considered successful in terms of signal transfer; 1) it must be possible to record volitional control of at least two independent muscles with a signal-to-noise ratio of at least 2, and 2) elicit sensory perception via nerve stimulation with a pulse less than 1 milliamperes (mA) amplitude and 1 ms width.
Measured: 13 months
Significant Improvement (p>0,05) in Myoelectric Control Using the "Assessment of Capacity for Myoelectric Control" (ACMC) Functionality Test
All enrolled patients will perform one pre-operative and two post-operative ACMC-tests. The test consists of 30 functional items grouped into 4 hand use areas: gripping, holding, releasing and coordinating. Each person's performance is rated on a 4-pt capability scale. As the items are identified, the rater scores the person's performance on a scale of 0-3 (0 = not capable, 1 = sometimes capable, 2= capable upon request, 3 = spontaneously capable). The results from the pre-operative and post-operative assessments will be statistically analyzed with the Rasch model. Post-operative tests will be conducted 8 and 56 weeks after surgery.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start26 Sep 2016
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Limb 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 study. Each patient is his/her own control.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital, Chalmers University of Technology, Vinnova, Promobilia Foundation, The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Paolo Sassu, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178890
- Sponsor's protocol ID
- 007618
- Acronym
- OHMG
- Status last verified
- May 2022
- First submitted
- 9 Feb 2017
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortiz-Catalan M, Hakansson B, Branemark R. An osseointegrated human-machine gateway for long-term sensory feedback and motor control of artificial limbs. Sci Transl Med. 2014 Oct 8;6(257):257re6. doi: 10.1126/scitranslmed.3008933.
PubMed 25298322Branemark R, Berlin O, Hagberg K, Bergh P, Gunterberg B, Rydevik B. A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J. 2014 Jan;96-B(1):106-13. doi: 10.1302/0301-620X.96B1.31905.
PubMed 24395320
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Osseointegrated Human-machine Gateway
- ClinicalTrials.gov ID
- NCT03178890
- Acronym / sponsor ID
- OHMG / 007618
- Conditions
- Upper Limb Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- IntegrumIndustry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital, Chalmers University of Technology, Vinnova, Promobilia Foundation, The Swedish Research Council
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 7 Jun 2017 (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.
Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin. This way of recordings is often unreliable, inconsistent and leading to high prosthetic abandonment rates for individuals with upper limb amputation. The use of implantable electrodes has been long thought as the solution for a more natural control of artificial limbs, as these offer access to long-term stable and physiologically appropriate sources of control, as well as the possibility to elicit appropriate sensory feedback via neurostimulation.
This Clinical Investigation (CI) is performed to clinically test and verify the safety and benefits of 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 artificial limbs. The bidirectional interface is based, and requires, the clinically established implant system for bone-anchored prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The feasibility of the device was initially proven through a proof-on-concept patient who has used the system without any adverse events for more than three years.
This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb amputation, when used within the intended purpose and according to instructions. The CI will be performed at Sahlgrenska University Hospital and Chalmers University of Technology, Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the last one approximately 13 months after the surgery. The study is prospective, where the patient is his/her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study. Each patient is his/her own control.
| Arm | Type | Receives |
|---|---|---|
| Osseointegrated Human Machine Gateway (OHMG) | Experimental | Device: OHMGPatients will be upgraded to the OHMG if already users of the OPRA Implant System, or implanted with the OPRA Implant System plus OHMG. Each patient will work as his/her own control before and after implantation of the OHMG. A single surgery is required to upgrade OPRA Implant System users to the OHMG, and no additional surgeries are required if the OHMG is implanted at the same time as the OPRA Implant System. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is an uni- or bi-lateral, transhumeral or transradial amputee
- At least 2 cm from the joint to the most proximal side of the fixture must be present.
- The patient has at least portion of biceps and triceps muscles present.
- The patient currently has, or has been accepted to have, the OPRA Implant System.
- The patient is younger than 70 and older than 17.
Key exclusion criteria (4 listed)
- Patient that has a significant cognitive impairment that prevents her/him from following instructions.
- The patient has any concurrent disease or conditions that might affect the treatment with the OHMG.
- The patient is pregnant.
- The patient is participating in another study.
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 |
|---|---|---|
| OHMGDevice will be implanted in all enrolled patients. | Device | Osseointegrated Human Machine Gateway (OHMG) |
Primary outcome
Percentage of total study population with Adverse Events graded as Serious Adverse Events (SAE)
Time frame: 13 months
Serious adverse events are characterized as a) led to death b) led to serious deterioration in health of the subject, that either results in (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or body function, (iii) in-patient or prolonged hospitalization, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.
Number of subjects with at least two independent myoelectric signals, and at least one sensory feedback location
Time frame: 13 months
For a case to be considered successful in terms of signal transfer; 1) it must be possible to record volitional control of at least two independent muscles with a signal-to-noise ratio of at least 2, and 2) elicit sensory perception via nerve stimulation with a pulse less than 1 milliamperes (mA) amplitude and 1 ms width.
Significant Improvement (p>0,05) in Myoelectric Control Using the "Assessment of Capacity for Myoelectric Control" (ACMC) Functionality Test
Time frame: 13 months
All enrolled patients will perform one pre-operative and two post-operative ACMC-tests. The test consists of 30 functional items grouped into 4 hand use areas: gripping, holding, releasing and coordinating. Each person's performance is rated on a 4-pt capability scale. As the items are identified, the rater scores the person's performance on a scale of 0-3 (0 = not capable, 1 = sometimes capable, 2= capable upon request, 3 = spontaneously capable). The results from the pre-operative and post-operative assessments will be statistically analyzed with the Rasch model. Post-operative tests will be conducted 8 and 56 weeks after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 25298322Ortiz-Catalan M, Hakansson B, Branemark R. An osseointegrated human-machine gateway for long-term sensory feedback and motor control of artificial limbs. Sci Transl Med. 2014 Oct 8;6(257):257re6. doi: 10.1126/scitranslmed.3008933.
- Background: PubMed 24395320Branemark R, Berlin O, Hagberg K, Bergh P, Gunterberg B, Rydevik B. A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J. 2014 Jan;96-B(1):106-13. doi: 10.1302/0301-620X.96B1.31905.
- 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.
Paolo Sassu, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHMG in people with Upper Limb Amputation, run by Integrum at 1 site in Sweden.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 May 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max Ortiz Catalan, PhD (+46708461065, maxo@chalmers.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of total study population with Adverse Events graded as Serious Adverse Events (SAE) (time frame: 13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03178890, which also lists 2 linked publications.
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 27 May 2022.