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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OPRA transhumeral.
- Who it may be relevant to
- Registry conditions: Amputation of Upper Limb. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Austria, Belgium, Germany, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Interventions
- Device OPRA transhumeral
Skeletal anchorage of amputation prostheses.
Primary outcome measures
- Implant Safety and Effectivness [Time frame: 2 years post implant surgery]
Secondary outcome measures (12)
- Implant Safety [Time frame: More than 10 years]
- Implant Safety [Time frame: More than 10 years]
- Implant safety [Time frame: More than 10 years]
- Implant safety [Time frame: More than 10 years]
- Implant effectiveness [Time frame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs]
- Implant effectiveness [Time frame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs]
- Implant effectivness [Time frame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs]
- Implant effectiveness [Time frame: Through study completion, an avarage of approximately 1 month.]
- Implant effectivness [Time frame: Through study completion, an avarage of approximately 1 month.]
- Implant effectivness. [Time frame: Through study completion, an avarage of approximately 1 month.]
- Implant effectiveness [Time frame: Through study completion, an avarage of approximately 1 month.]
- Implant effectivness [Time frame: Through study completion, an avarage of approximately 1 month.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Hannover Medical School — Hanover
- University Hospital Tübing — Tübingen
Australia · 1 center
- The Alfred Hospital — Melbourne
Austria · 1 center
- Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger — Vienna
Belgium · 1 center
- University Hospital Ghent, UX Ghent — Ghent
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT06753110 · 0092