An interventional study of Aptis PRUJ Prosthesis in Arthritis, Unstable Radial Head and Proximal Radioulnar Joint Instability, sponsored by Aptis Medical. Recruiting at 7 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Aptis Medical · Not applicable, Interventional, and Treatment
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
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.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 84 is below the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Aptis Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
Exclusion Criteria:
1. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
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 (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, , 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 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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational Aptis PRUJ Prothesis treatment
Device: Aptis PRUJ Prosthesis
A prosthetic implant for replacement of the proximal radial ulna joint.
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
Time frame: 24 months
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
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Change in disability index assessed at all follow-up time points via DASH
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Radiolucencies around radial stem and ulnar screws
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Subsidence of radial component
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Screw breakage
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Ulnar variance
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Use of other concomitant medications
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative recovery time (return to daily activities/work)
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative rehabilitation details
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Nov 2029, 67 months after the start.
Of 167 interventional studies with no phase under Arthritis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 65. This study's planned 67 months is above that.
How these figures are worked out, and which studies are left out of them.
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