ArthritisNCT05796908
Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
A study testing Aptis PRUJ Prosthesis in people with Arthritis and Unstable Radial Head, run by Aptis Medical at 7 sites in United States.
Trial summary
A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability
- What is being tested?
- Aptis PRUJ Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Apr 2024to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Patient is skeletally mature and under 85 years of age.
- Patient has a painful, unstable radial head due to degeneration or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radioulnar joint and is otherwise
- Patients willing and able to understand and sign the informed consent. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the post-operative rehabilitation and follow-up visits per protocol.
Who cannot join
- 1. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
- Pain at terminal flexion/extension
- Pain throughout ROM with loss of motion in terminal flexion and/or extension 3. Patients with an allergy to the implant materials 4. Active systemic infection or infection at the site of surgery 5. Physical interference with or by other prostheses during implantation or use 6. Have a Body Mass Index (BMI) greater than 35 kg/m2 7. Have any mental or psychological disorder that would impair the ability to complete the study questionnaires 8. Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.) 9. Have any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation 10. Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance 11. Skin, bone, circulatory and/or neurological deficiency at or affecting the implantation site 12. Prisoners 13. Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy 14. Women who are pregnant or breast-feeding or are planning to become pregnant during the study.
- 15. Patients with a documented history of uncontrolled diabetes. 16. Patients with known allergies against anesthesia. 17. Patients with a history of or current drug and/or alcohol abuse 18. Patients unlikely to cooperate or are legally incompetent. 19. Patients with legal involvement, including an active claim for workman's compensation, or any other issue that would hinder completion of the two-year follow period.
- 20. Patients who are participating or have participated in any other study involving an investigational drug or device within the past 3 months.
- Intra-operative Exclusion Criteria
Show all 10Show fewer
- Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
- A proximal radio ulnar joint that cannot be reduced intraoperatively
- Inadequate bone quality that would allow for implant placement
- Not enough radius bone proximally for device implantation
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Danielle Koehler, 610-402-1657, danielle.koehler@jefferson.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
John Fitzhenry, 617-726-1569, jrfitzhenry@mgh.harvard.edu
- Recruiting
Indiana Hand to Shoulder Center
Carmel, Indiana, 46260
Melanie Glover, 317-802-2880, mglover@orthoindy.com
- Recruiting
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, 45459
Laura Peterson, 937-439-6483, lpeterson@oaswo.com
- Recruiting
Kleinert Kutz Hand Care Center
Louisville, Kentucky, 40202
Ann Jerde, 502-852-5251, ann.jerde@louisville.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Steven Liss, 414-955-3218, sliss@mcw.edu
John Gardner, +44 7345 02 3334, sgardner@mcra.com
- Withdrawn
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders
Read the detailed description
This is a prospective, multi-center, single-arm clinical trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.
- Conditions
- Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability, Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
- Being tested
- Aptis PRUJ Prosthesis
- Keywords
- PRUJ, Disorders, radio-humeral joint, proximal radioulnar joint
- Medical subject headings
- Arthritis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptis PRUJ ProsthesisDevice
A prosthetic implant for replacement of the proximal radial ulna joint.
| Study group | Role | What they receive |
|---|---|---|
| Aptis PRUJ Prothesis | Experimental | Investigational Aptis PRUJ Prothesis treatment Receives: Device: Aptis PRUJ Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sucess
A non-inferiority composite primary endpoint for effectiveness and safety, where a subject is considered a success if they meet the following criteria:
- Mayo Elbow Performance Score, where success is defined as Good or Excellent at 24 months; and
- Absence of radiographic evidence of periprosthetic osteolysis (radiolucent line >2mm around entire radial stem and ulnar screws), and no screw breakage at 24 months; and
- Absence of device-related serious adverse events including any revisions and removals through 24 months
Measured: 24 months
Secondary outcomes (10)
Effectiveness
The following secondary endpoints will evaluate the effectiveness of the investigational device:
- Pre- vs. Post-operative function assessed via Mayo Elbow Performance Score
- Mayo Subscores
- Pain
- Range of motion
- Instability
- Function
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Changes in overall health at all follow-up time points assessed via SF-36
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Change in disability index assessed at all follow-up time points via DASH
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Radiolucencies around radial stem and ulnar screws
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Subsidence of radial component
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Screw breakage
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Ulnar variance
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Use of other concomitant medications
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative recovery time (return to daily activities/work)
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative rehabilitation details
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start12 Apr 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptis Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- John Scheker, Study chair, Aptis Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796908
- Sponsor's protocol ID
- AP-PRO-001
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
- ClinicalTrials.gov ID
- NCT05796908
- Acronym / sponsor ID
- AP-PRO-001
- Conditions
- Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability, Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
- Keywords
- PRUJ, Disorders, radio-humeral joint, proximal radioulnar joint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Aptis MedicalIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders
Detailed description
This is a prospective, multi-center, single-arm clinical trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aptis PRUJ Prothesis | Experimental | Device: Aptis PRUJ ProsthesisInvestigational Aptis PRUJ Prothesis treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
Key exclusion criteria (10 listed)
- 1. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
- 15. Patients with a documented history of uncontrolled diabetes. 16. Patients with known allergies against anesthesia. 17. Patients with a history of or current drug and/or alcohol abuse 18. Patients unlikely to cooperate or are legally incompetent. 19. Patients with legal involvement, including an active claim for workman's compensation, or any other issue that would hinder completion of the two-year follow period.
- 20. Patients who are participating or have participated in any other study involving an investigational drug or device within the past 3 months.
- Intra-operative Exclusion Criteria
- Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aptis PRUJ ProsthesisA prosthetic implant for replacement of the proximal radial ulna joint. | Device | Aptis PRUJ Prothesis |
Primary outcome
Sucess
Time frame: 24 months
A non-inferiority composite primary endpoint for effectiveness and safety, where a subject is considered a success if they meet the following criteria: * Mayo Elbow Performance Score, where success is defined as Good or Excellent at 24 months; and * Absence of radiographic evidence of periprosthetic osteolysis (radiolucent line >2mm around entire radial stem and ulnar screws), and no screw breakage at 24 months; and * Absence of device-related serious adverse events including any revisions and removals through 24 months
10 secondary outcomes
Effectiveness
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Scheker study chair
Aptis Medical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aptis PRUJ Prosthesis in people with Arthritis and Unstable Radial Head, run by Aptis Medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Villagomez (5716747734, avillagomez@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sucess (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.