No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Aptis Medical · Industry
Who this trial is looking for
This trial is looking for people with joint pain in the arm caused by unstable radial head issues. Participants will undergo a procedure using the Aptis PRUJ prosthesis and will need to follow post-surgery care guidelines.
Are You a Good Fit for This Trial?
Rules you outSevere arthritisActive infectionUncontrolled diabetesAllergy to anesthesia
You may be able to join if
I am under 85 years old.
I have joint pain and instability in my arm.
I can understand and sign consent paperwork.
I agree to follow post-operative rehabilitation.
I am skeletally mature.
You may not be able to join if
I have severe arthritis in my arm.
I have an infection in my body or at the surgery site.
I weigh more than 35 kg/m2.
I have a history of drug or alcohol abuse.
I am currently pregnant or breastfeeding.
I have any condition that prevents me from attending follow-up visits.
I have mental health issues that affect my study participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* In order to be eligible to participate in this study, subjects must meet all of the following criteria:
1. Patient is skeletally mature and under 85 years of age.
2. Patient has a painful, unstable radial head due to degeneration or post-traumatic disabilities presenting …
Inclusion Criteria:
* In order to be eligible to participate in this study, subjects must meet all of the following criteria:
1. Patient is skeletally mature and under 85 years of age.
2. 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
3. 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.
Exclusion Criteria:
* 1\. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
1. Pain at terminal flexion/extension
2. 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
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
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