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 (ReTHro)

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation of Upper Limb
• Intervention / Treatment: Device: OPRA transhumeral

Detailed Description

All subjects that will be enrolled in this investigation should have been treated with the OPRA Implant System for a transhumeral unilateral or bilateral amputation and completed the second stage surgery (S2) and had at least 6 months of usage experience with the OPRA Implant System before enrolment.

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chief Medical Officer, MD; Phone Number: +46 706753499; Email: karin.ganlov@integrum.se
• Study Contact Backup: Name: Head of Clinical Operations, M.Sc; Phone Number: +46766015026; Email: johan.blechert@integrum.se

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Not yet recruiting
      • The Alfred Hospital
      • Contact: Margareth Angliss; Phone Number: 0061 48 855 1860; Email: m.angliss@alfred.org.au
      • Principal Investigator: Frank Bruscino-Riola, Md
• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
    • Contact: Anna Bösendorfer; Phone Number: +43 1 40400 61098; Email: anna.boesendorfer@meduniwien.ac.at
    • Principal Investigator: Oskar Aszmann, Professor
    • Sub-Investigator: Anna Bösendorfer
• Belgium
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • University Hospital Ghent, UX Ghent
    • Contact: Bram Cornette, MD; Phone Number: 09332 21 11; Email: bram.cornette@uzgent.be
    • Principal Investigator: Wim Vanhove, MD
• Germany
  • Hannover, Germany, 30625
    • Not yet recruiting
    • Hannover Medical School
    • Contact: Magnus Kalff, M.Sc; Phone Number: 00495115322099; Email: Kalff.magnus@mh-hannover.de
    • Principal Investigator: Jennifer Ernst, MD
  • Tübingen, Germany, 72076
    • Not yet recruiting
    • University Hospital Tübing
    • Contact: Jana Ritter, RN; Phone Number: 1038 0049 7071 606; Email: jritter@bgu-teubingen.de
    • Contact: Marie Reumann, RN; Phone Number: 0049 7071 606; Email: mreumann@bgu-teubingen.de
    • Principal Investigator: Jonas C Kolbenschlag, MD
• Netherlands
  • Groningen, Netherlands, 9700
    • Not yet recruiting
    • University Medical Center Groningen
    • Contact: Joyce Vrijsen; Phone Number: 0031 (50) 361 2802; Email: j.vrijsen@umcg.nl
    • Contact: Corry Vende Sluis, MD; Phone Number: 0031 (50) 3617665; Email: c.k.van.der.sluis@umcg.nl
    • Principal Investigator: Paul C Jutte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Uni/bilaterally transhumeral amputated; OPRA transhumeral	Device: OPRA transhumeral; Skeletal anchorage of amputation prostheses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Safety	• Implant survival rate, after 6 months, and 1-, 5-, 10- and ˃10-years post implant surgery. Calculated as the number of implants still in situ after 6 months, 1-, 5-, 10- and ˃10-years after completion of surgery divided by the number of implants at risk	More than 10 years
Implant Safety	• Implant survival time Measured as the time from completion of surgery to implant loss or time of last observation without known implant loss.	More than 10 years
Implant safety	• Presence of biological complications Measured as the number of the following complications taking place from time of surgery to time of implant loss or time of last observation without known implant loss: Infections; Skin complications; Skeletal complications	More than 10 years
Implant safety	• 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	More than 10 years
Implant effectiveness	• Functionality evaluations. Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Set of questions, score 1-5. Higher score worse.	6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs
Implant effectiveness	Funtionallity evaluation. Patient-Reported Outcomes Measurements Information System(PROMIS) - Upper Extremity, Short Form 7a. Seven questions, score 5-1. Higher score better.	6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Implant effectivness	Functionality evaluation. Southampton Hand Assessment Procedure (SHAP). Funtionality test performed, time meassured. Calculated score 0-100. Higher score better.	6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Implant effectiveness	• Physical evaluation - Short Form (36) Health Survey Eleven questions. Various alternatives.	Through study completion, an avarage of approximately 1 month.
Implant effectivness	Physical evaluation. Range of Motion Test. Degree of movement around a joint. Higher score better	Through study completion, an avarage of approximately 1 month.
Implant effectivness.	Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.	Through study completion, an avarage of approximately 1 month.
Implant effectiveness	• Satisfaction of use. Prosthetic use satisfaction. Numeric rating scale, 0-10. High score are better.	Through study completion, an avarage of approximately 1 month.
Implant effectivness	Satisfaction of use. OPRA™ implant system satisfaction. Numeric rating scale, 0-10. High score are better.	Through study completion, an avarage of approximately 1 month.
Implant effectiveness	• 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.	Through study completion, an avarage of approximately 1 month.

Collaborators and Investigators

• Sponsor: Integrum

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Skeletal anchorage of amputation prostheses.; Osseoanchored Prosthesis
• Other Study ID Numbers: 0092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data specified in the outcome meassures
• IPD Sharing Time Frame: 2026
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No