Amputation of Upper LimbReTHroNCT06753110
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
A study testing OPRA transhumeral in people with Amputation of Upper Limb, run by Integrum at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation of Upper Limb
- What is being tested?
- OPRA transhumeral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 19 Feb 2025to Mar 2026
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject not willing to consent
- Subject implanted with the e-OPRA system at the humeral level.
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Hannover Medical School
Hanover, 30625
Magnus Kalff, M.Sc, 00495115322099, Kalff.magnus@mh-hannover.de
Jennifer Ernst, MD
- Not yet recruiting
University Hospital Tübing
Tübingen, 72076
Jana Ritter, RN, 0049 7071 606 ext. 1038, jritter@bgu-teubingen.de
Marie Reumann, RN, 0049 7071 606, mreumann@bgu-teubingen.de
Australia1 site, 1 recruiting
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Margareth Angliss, 0061 48 855 1860, m.angliss@alfred.org.au
Frank Bruscino-Riola, Md
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, 1090
Anna Bösendorfer, +43 1 40400 61098, anna.boesendorfer@meduniwien.ac.at
Oskar Aszmann, Professor
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospital Ghent, UX Ghent
Ghent, 9000
Bram Cornette, MD, 09332 21 11, bram.cornette@uzgent.be
Wim Vanhove, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center Groningen
Groningen, 9700
Joyce Vrijsen, 0031 (50) 361 2802, j.vrijsen@umcg.nl
Corry Vende Sluis, MD, 0031 (50) 3617665, c.k.van.der.sluis@umcg.nl
About this study
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.
Read the 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.
- Conditions
- Amputation of Upper Limb
- Being tested
- OPRA transhumeral
- Keywords
- Skeletal anchorage of amputation prostheses., Osseoanchored Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPRA transhumeralDevice
Skeletal anchorage of amputation prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Uni/bilaterally transhumeral amputated | Other | OPRA transhumeral Receives: Device: OPRA transhumeral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years post implant surgery
Secondary outcomes (13)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Implant effectiveness
- Physical evaluation - Short Form (36) Health Survey Eleven questions. Various alternatives.
Measured: 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
Measured: Through study completion, an avarage of approximately 1 month.
Implant effectivness.
Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an avarage of approximately 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start19 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Upper LimbStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753110
- Sponsor's protocol ID
- 0092
- Acronym
- ReTHro
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data specified in the outcome meassures