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

Not Applicable

Recruiting

• Conditions: Amputation of Upper Limb

• Registration Number: NCT06753110
• Lead Sponsor: Integrum

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.

Detailed Description

All subjects that will be enrolled in this investigation should have been treated with the OPRA TM Implant System for a transhumeral unilateral or bilateral amputation completed before 01-Jan-2024.

This retrospective, non-interventional, clinical investigation is designed as a multicenter, multinational, cohort investigation for long-term follow-up of safety and efficacy endpoints. The investigation will also include prospective visit(s) for enrollment of subjects and collection of present data on device functionality and the use of the device.

No control group or comparator will be used in this investigation.

All patient reported outcome questionnaires used in the investigation will be available at the investigation site for completion by the subjects during one of the subjects' visits to the site. Depending on the subjects' preferences it will also be possible to provide those questionnaires to the subjects, through use of regular mail, email or through an electronic Patient Reported Outcome system (ePRO). It will be possible for the subjects to complete the questionnaires either on paper, electronically or over phone, depending on their preferences.

Preferably, the subjects prosthesis functional tests should be performed as part of the follow-up visit at the site. The tests may also be performed remotely, depending on subjects' preferences. If done remotely, this will require the functionality test being performed during a videoconference with the test administrator. No photos or video-recordings (if conducted according to the sites normal practice) of the performed tests will be part of the investigation documentation, only the related medical record notes will be used as source data for those parameters.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-31
• Study Start: 2025-02-19
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implant Safety and Effectivness	2 years post implant surgery	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.

Secondary Outcome Measures

Name	Time	Method
Implant Safety	More than 10 years	• Implant survival time Measured as the time from completion of surgery to implant loss or time of last observation without known implant loss.
Implant safety	More than 10 years	• Presence of Mechanical complications; Mechanical complications related to implant, abutment or abutment screw. Measured as the number of mechanical complications taking place from time of surgery to implant loss our time of last observation without known implant loss, presented per category: * Implant related; * Abutment related; * Abutment screw related
Implant effectiveness	Through study completion, an avarage of approximately 1 month.	• Level of embodiment of the Prosthesis Numerical Rating Scale. Six personal questions. Score 0-10. Second question is 0 better. For the five other question 10 is better.
Implant effectivness	Through study completion, an avarage of approximately 1 month.	Satisfaction of use. OPRA™ implant system satisfaction. Numeric rating scale, 0-10. High score are better.
Implant effectivness.	Through study completion, an avarage of approximately 1 month.	Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.

Trial Locations

Locations (7)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

University Hospital Ghent, UX Ghent; 🇧🇪 Ghent, Belgium

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hannover Medical School; 🇩🇪 Hannover, Germany

University Hospital Tübing; 🇩🇪 Tübingen, Germany

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

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