Osseointegrated Human-Machine Gateway

NCT ID: NCT03178890

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-26
• Study Completion Date: 2024-05-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osseointegrated Human Machine Gateway (OHMG)

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.

Group Type: EXPERIMENTAL

OHMG

Intervention Type: DEVICE

Device will be implanted in all enrolled patients.

Interventions

OHMG

Device will be implanted in all enrolled patients.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Chalmers University of Technology

OTHER

Sponsor Role: collaborator

Vinnova

OTHER_GOV

Sponsor Role: collaborator

Promobilia Foundation

OTHER

Sponsor Role: collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Integrum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Sassu, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Max Ortiz Catalan, PhD

Role: CONTACT

maxo@chalmers.se

+46708461065

Justyna Kolankowska, MSc

Role: CONTACT

justyna.kolankowska@integrum.se

+46760616076

Facility Contacts

Paolo Sassu, MD

Role: primary

paolo.sassu@vgregion.se

References

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.

Reference Type: BACKGROUND

PMID: 25298322 (View on PubMed)

Branemark 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.

Reference Type: BACKGROUND

PMID: 24395320 (View on PubMed)

Other Identifiers

007618

Identifier Type: -

Identifier Source: org_study_id