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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06753110
Registration number
NCT06753110
Ethics application status
Date submitted
17/12/2024
Date registered
31/12/2024
Date last updated
3/07/2025
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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0092
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Universal Trial Number (UTN)
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Trial acronym
ReTHro
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amputation of Upper Limb
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - OPRA transhumeral
Other: Uni/bilaterally transhumeral amputated - OPRA transhumeral
Treatment: Devices: OPRA transhumeral
Skeletal anchorage of amputation prostheses.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Implant Safety and Effectivness
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Assessment method [1]
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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.
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Timepoint [1]
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2 years post implant surgery
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Secondary outcome [1]
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Implant Safety
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Assessment method [1]
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• 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
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Timepoint [1]
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More than 10 years
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Secondary outcome [2]
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Implant Safety
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Assessment method [2]
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• Implant survival time Measured as the time from completion of surgery to implant loss or time of last observation without known implant loss.
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Timepoint [2]
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More than 10 years
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Secondary outcome [3]
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Implant safety
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Assessment method [3]
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• 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
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Timepoint [3]
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More than 10 years
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Secondary outcome [4]
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Implant safety
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Assessment method [4]
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• 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
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Timepoint [4]
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More than 10 years
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Secondary outcome [5]
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Implant effectiveness
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Assessment method [5]
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• Functionality evaluations. Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Set of questions, score 1-5. Higher score worse.
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Timepoint [5]
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6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs
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Secondary outcome [6]
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Implant effectiveness
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Assessment method [6]
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Funtionallity evaluation. Patient-Reported Outcomes Measurements Information System(PROMIS) - Upper Extremity, Short Form 7a. Seven questions, score 5-1. Higher score better.
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Timepoint [6]
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6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
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Secondary outcome [7]
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Implant effectivness
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Assessment method [7]
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Functionality evaluation. Southampton Hand Assessment Procedure (SHAP). Funtionality test performed, time meassured. Calculated score 0-100. Higher score better.
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Timepoint [7]
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6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
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Secondary outcome [8]
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Implant effectiveness
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Assessment method [8]
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• Physical evaluation - Short Form (36) Health Survey Eleven questions. Various alternatives.
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Timepoint [8]
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Through study completion, an avarage of approximately 1 month.
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Secondary outcome [9]
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Implant effectivness
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Assessment method [9]
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Physical evaluation. Range of Motion Test. Degree of movement around a joint. Higher score better
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Timepoint [9]
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Through study completion, an avarage of approximately 1 month.
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Secondary outcome [10]
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Implant effectivness.
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Assessment method [10]
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Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.
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Timepoint [10]
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Through study completion, an avarage of approximately 1 month.
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Secondary outcome [11]
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Implant effectiveness
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Assessment method [11]
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• Satisfaction of use. Prosthetic use satisfaction. Numeric rating scale, 0-10. High score are better.
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Timepoint [11]
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Through study completion, an avarage of approximately 1 month.
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Secondary outcome [12]
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Implant effectivness
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Assessment method [12]
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Satisfaction of use. OPRA™ implant system satisfaction. Numeric rating scale, 0-10. High score are better.
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Timepoint [12]
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Through study completion, an avarage of approximately 1 month.
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Secondary outcome [13]
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Implant effectiveness
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Assessment method [13]
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• 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.
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Timepoint [13]
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Through study completion, an avarage of approximately 1 month.
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject not willing to consent
* Subject implanted with the e-OPRA system at the humeral level.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2026
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Country [2]
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Belgium
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State/province [2]
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Ghent
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Country [3]
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Germany
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State/province [3]
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Hannover
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Country [4]
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Germany
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State/province [4]
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Tübingen
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Country [5]
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Netherlands
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State/province [5]
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Groningen
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Integrum
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06753110
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Chief Medical Officer, MD
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Address
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Country
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Phone
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+46 706753499
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06753110
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