A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients

NCT06753110 | Recruiting

• 1 other identifier: 0092
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 5

Brief Summary

This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to \>20 years in function. It will collect and evaluate clinical data on the safety and performance of the OPRA™ Implant System when used on transhumeral amputees and within the scope of the intended use.

Conditions

Amputation of Upper Limb

Keywords

Skeletal anchorage of amputation prostheses.; Osseoanchored Prosthesis

Outcome Measures

Primary Outcomes (1)

• Implant Safety and Effectivness

  Implant safety: \* Implant survival rate 2 years post implant surgery. Calculated the number of implants still in situ at time of the follow-up visit, 2 years after completion of implant surgery divided by the number of implants at risk. Effectivness: \* Change in prosthetic use. Measured as time prosthesis used before implant surgery compared with time prosthesis used at time of the follow-up visit. Categorized as: * Hours per day * Days per week.

  2 years post implant surgery

Secondary Outcomes (13)

• Implant Safety

  More than 10 years

• Implant Safety

  More than 10 years

• Implant safety

  More than 10 years

• Implant safety

  More than 10 years

• Implant effectiveness

  6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs

Study Arms (1)

Uni/bilaterally transhumeral amputated

OTHER

OPRA transhumeral

Device: OPRA transhumeral

Interventions

OPRA transhumeral DEVICE

Skeletal anchorage of amputation prostheses.

Uni/bilaterally transhumeral amputated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral amputation
• OPRA™ implant system placed, and with S2 completed before 01-Jan-2024
• Having a minimum of 6 months of follow-up between S2 and enrolment

You may not qualify if:

• Subject not willing to consent
• Subject implanted with the e-OPRA system at the humeral level.

Sponsors & Collaborators

• Integrum: lead

Study Sites (6)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA

Vienna, 1090, Austria

RECRUITING

University Hospital Ghent, UX Ghent

Ghent, 9000, Belgium

NOT YET RECRUITING

Hannover Medical School

Hanover, 30625, Germany

NOT YET RECRUITING

University Hospital Tübing

Tübingen, 72076, Germany

NOT YET RECRUITING

University Medical Center Groningen

Groningen, 9700, Netherlands

NOT YET RECRUITING

Central Study Contacts

Chief Medical Officer, MD

CONTACT

+46 706753499; karin.ganlov@integrum.se

Head of Clinical Operations, M.Sc

CONTACT

+46766015026; johan.blechert@integrum.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: As described in the title this is a long term safety and efficacy follow up on subjects that received an transhumeral implant uni/bilaterlly before Jan 2024, and mainly looking at Retrospective data gathered from medical records.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: February 19, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 2026
• Access Criteria: The participating investigators will have full access of the Clinical Investigation Report as part of the study file for archiving. After main publication is performed, individual investigators will have access to the complete data on request.

Locations

AU (1); DE (2); BE (1); NL (1)