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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

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
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
Secondary ID [1] 0 0
0092
Universal Trial Number (UTN)
Trial acronym
ReTHro
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amputation of Upper Limb 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Safety and Effectivness
Timepoint [1] 0 0
2 years post implant surgery
Secondary outcome [1] 0 0
Implant Safety
Timepoint [1] 0 0
More than 10 years
Secondary outcome [2] 0 0
Implant Safety
Timepoint [2] 0 0
More than 10 years
Secondary outcome [3] 0 0
Implant safety
Timepoint [3] 0 0
More than 10 years
Secondary outcome [4] 0 0
Implant safety
Timepoint [4] 0 0
More than 10 years
Secondary outcome [5] 0 0
Implant effectiveness
Timepoint [5] 0 0
6 months, 1yr, 2yrs, 5yrs, 10yrs, > 10yrs
Secondary outcome [6] 0 0
Implant effectiveness
Timepoint [6] 0 0
6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Secondary outcome [7] 0 0
Implant effectivness
Timepoint [7] 0 0
6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs
Secondary outcome [8] 0 0
Implant effectiveness
Timepoint [8] 0 0
Through study completion, an avarage of approximately 1 month.
Secondary outcome [9] 0 0
Implant effectivness
Timepoint [9] 0 0
Through study completion, an avarage of approximately 1 month.
Secondary outcome [10] 0 0
Implant effectivness.
Timepoint [10] 0 0
Through study completion, an avarage of approximately 1 month.
Secondary outcome [11] 0 0
Implant effectiveness
Timepoint [11] 0 0
Through study completion, an avarage of approximately 1 month.
Secondary outcome [12] 0 0
Implant effectivness
Timepoint [12] 0 0
Through study completion, an avarage of approximately 1 month.
Secondary outcome [13] 0 0
Implant effectiveness
Timepoint [13] 0 0
Through study completion, an avarage of approximately 1 month.

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject not willing to consent
* Subject implanted with the e-OPRA system at the humeral level.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Ghent
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Germany
State/province [4] 0 0
Hannover
Country [5] 0 0
Germany
State/province [5] 0 0
Tübingen
Country [6] 0 0
Netherlands
State/province [6] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Integrum
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer, MD
Address 0 0
Country 0 0
Phone 0 0
+46 706753499
Fax 0 0
Email 0 0
[email protected]
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