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
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 details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06753110
Intervention or treatment
DEVICE: OPRA transhumeral
Conditions
- Amputation of Upper Limb
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Research sites nearby
Closest Location:
The Alfred Hospital
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The Alfred Hospital
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Integrum
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: Uni/bilaterally transhumeral amputated
| Device: OPRA transhumeral |
What is the study measuring?
Primary Outcome
| 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
| 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. |
References
Clinical Trials Gov: 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 PatientsOther trials to consider
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