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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Skeletal anchorage of amputation prostheses.
The Alfred Hospital
Melbourne, Victoria, Australia
NOT_YET_RECRUITINGMedical University of Vienna Clinical laboratory for bionic limb reconstruction Währinger Gürtel 18-20 1090 Vienna, AUSTRIA
Vienna, Austria
RECRUITINGUniversity Hospital Ghent, UX Ghent
Ghent, Belgium
NOT_YET_RECRUITINGHannover Medical School
Hanover, Germany
NOT_YET_RECRUITINGUniversity Hospital Tübing
Tübingen, Germany
NOT_YET_RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
NOT_YET_RECRUITINGImplant 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.
Time frame: 2 years post implant surgery
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Implant effectiveness
• Physical evaluation - Short Form (36) Health Survey Eleven questions. Various alternatives.
Time frame: 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
Time frame: Through study completion, an avarage of approximately 1 month.
Implant effectivness.
Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an avarage of approximately 1 month.
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