Amputation of Upper Limb
Conditions
Keywords
Skeletal anchorage of amputation prostheses., Osseoanchored Prosthesis
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 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
DEVICEOPRA transhumeral
Skeletal anchorage of amputation prostheses.
Sponsors
Integrum
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Safety and Effectivness | 2 years post implant surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Safety | More than 10 years | • 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 |
| Implant safety | More than 10 years | • 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 |
| Implant effectiveness | 6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs | • Functionality evaluations. Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Set of questions, score 1-5. Higher score worse. |
| Implant effectivness | 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs | Functionality evaluation. Southampton Hand Assessment Procedure (SHAP). Funtionality test performed, time meassured. Calculated score 0-100. Higher score better. |
| Implant effectivness. | Through study completion, an avarage of approximately 1 month. | Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse. |
Countries
Australia, Austria, Belgium, Germany, Netherlands
Contacts
Primary ContactChief Medical Officer, MD
Backup ContactHead of Clinical Operations, M.Sc
Outcome results
None listed