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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis; Unstable Radial Head; Proximal Radioulnar Joint Instability; Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
• Intervention / Treatment: Device: Aptis PRUJ Prosthesis

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer N Jennings; Phone Number: 12027423861; Email: JJennings@mcra.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aptis PRUJ Prothesis; Investigational Aptis PRUJ Prothesis treatment	Device: Aptis PRUJ Prosthesis; A prosthetic implant for replacement of the proximal radial ulna joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 SubscoresPainRange of motionInstabilityFunction	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	6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness	Change in disability index assessed at all follow-up time points via DASH	6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic	Radiolucencies around radial stem and ulnar screws	6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic	Subsidence of radial component	6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic	Screw breakage	6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic	Ulnar variance	6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic	Use of other concomitant medications	6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic	Post-operative recovery time (return to daily activities/work)	6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic	Post-operative rehabilitation details	6 weeks, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Aptis Medical
• Collaborators: MCRA
• Investigators: Study Chair: John Scheker, Aptis Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Disorders; PRUJ; radio-humeral joint; proximal radioulnar joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Joint Instability
• Other Study ID Numbers: AP-PRO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes