Clinical trial NCT06753110: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation of Upper Limb
Keywords: Skeletal anchorage of amputation prostheses.
Osseoanchored Prosthesis
Lead sponsor: Integrum
Sponsor class: INDUSTRY
First posted: 2024-12-31
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Implant Safety and Effectivness
timeFrame: 2 years post implant surgery
Secondary outcomes:
measure: Implant Safety
timeFrame: More than 10 years
measure: Implant Safety
timeFrame: More than 10 years
measure: Implant safety
timeFrame: More than 10 years
measure: Implant safety
timeFrame: More than 10 years
measure: Implant effectiveness
timeFrame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs
measure: Implant effectiveness
timeFrame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
measure: Implant effectivness
timeFrame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
measure: Implant effectiveness
timeFrame: Through study completion, an avarage of approximately 1 month.
measure: Implant effectivness
timeFrame: Through study completion, an avarage of approximately 1 month.
measure: Implant effectivness.
timeFrame: Through study completion, an avarage of approximately 1 month.
measure: Implant effectiveness
timeFrame: Through study completion, an avarage of approximately 1 month.
measure: Implant effectivness
timeFrame: Through study completion, an avarage of approximately 1 month.
measure: Implant effectiveness
timeFrame: Through study completion, an avarage of approximately 1 month.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Vienna
country: Austria
facility: Medical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
city: Ghent
country: Belgium
facility: University Hospital Ghent, UX Ghent
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hannover
country: Germany
facility: Hannover Medical School
city: Tübingen
country: Germany
facility: University Hospital Tübing
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: