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NCT Number: NCT06753110

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.

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Key information

Conditions

Amputation of Upper Limb

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OPRA transhumeral

Device

Skeletal anchorage of amputation prostheses.

Primary outcomes

  1. Implant Safety and Effectivness

    Time frame: 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 outcomes

  1. Implant Safety

    Time frame: 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

  2. Implant Safety

    Time frame: More than 10 years

    • Implant survival time Measured as the time from completion of surgery to implant loss or time of last observation without known implant loss.

  3. Implant safety

    Time frame: 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

  4. Implant safety

    Time frame: More than 10 years

    • 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

  5. Implant effectiveness

    Time frame: 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.

  6. Implant effectiveness

    Time frame: 6 months, 1yr, 2yrs, 5yrs, 10yrs, >10yrs

    Funtionallity evaluation. Patient-Reported Outcomes Measurements Information System(PROMIS) - Upper Extremity, Short Form 7a.

    Seven questions, score 5-1. Higher score better.

  7. Implant effectivness

    Time frame: 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.

  8. Implant effectiveness

    Time frame: Through study completion, an avarage of approximately 1 month.

    • Physical evaluation - Short Form (36) Health Survey Eleven questions. Various alternatives.

  9. Implant effectivness

    Time frame: Through study completion, an avarage of approximately 1 month.

    Physical evaluation. Range of Motion Test. Degree of movement around a joint. Higher score better

  10. Implant effectivness.

    Time frame: Through study completion, an avarage of approximately 1 month.

    Physical examination. Pain questions. Numeric Range Scale 0-10. High scores mean worse.

  11. Implant effectiveness

    Time frame: Through study completion, an avarage of approximately 1 month.

    • Satisfaction of use. Prosthetic use satisfaction. Numeric rating scale, 0-10. High score are better.

  12. Implant effectivness

    Time frame: Through study completion, an avarage of approximately 1 month.

    Satisfaction of use. OPRA™ implant system satisfaction. Numeric rating scale, 0-10. High score are better.

  13. Implant effectiveness

    Time frame: Through study completion, an avarage of approximately 1 month.

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer, MD

CONTACT

[email protected]

+46 706753499

Head of Clinical Operations, M.Sc

CONTACT

[email protected]

+46766015026

Sponsors and collaborators

Lead sponsor

Integrum

Industry

Registry information

Acronym: ReTHro

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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