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Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.

Primary Purpose

Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aptis PRUJ Prosthesis
Sponsored by
Aptis Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring PRUJ, Disorders, radio-humeral joint, proximal radioulnar joint

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Aptis PRUJ Prothesis

    Arm Description

    Investigational Aptis PRUJ Prothesis treatment

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Effectiveness
    Changes in overall health at all follow-up time points assessed via SF-36
    Effectiveness
    Change in disability index assessed at all follow-up time points via DASH
    Radiographic
    Radiolucencies around radial stem and ulnar screws
    Radiographic
    Subsidence of radial component
    Radiographic
    Screw breakage
    Radiographic
    Ulnar variance
    Health Economic
    Use of other concomitant medications
    Health Economic
    Post-operative recovery time (return to daily activities/work)
    Health Economic
    Post-operative rehabilitation details

    Full Information

    First Posted
    March 10, 2023
    Last Updated
    March 21, 2023
    Sponsor
    Aptis Medical
    Collaborators
    MCRA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796908
    Brief Title
    Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    November 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aptis Medical
    Collaborators
    MCRA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aptis PRUJ Prothesis
    Arm Type
    Experimental
    Arm Description
    Investigational Aptis PRUJ Prothesis treatment
    Intervention Type
    Device
    Intervention Name(s)
    Aptis PRUJ Prosthesis
    Intervention Description
    A prosthetic implant for replacement of the proximal radial ulna joint.
    Primary Outcome Measure Information:
    Title
    Sucess
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Effectiveness
    Description
    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
    Title
    Effectiveness
    Description
    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
    Title
    Effectiveness
    Description
    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
    Title
    Radiographic
    Description
    Radiolucencies around radial stem and ulnar screws
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Radiographic
    Description
    Subsidence of radial component
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Radiographic
    Description
    Screw breakage
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Radiographic
    Description
    Ulnar variance
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Health Economic
    Description
    Use of other concomitant medications
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Health Economic
    Description
    Post-operative recovery time (return to daily activities/work)
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months
    Title
    Health Economic
    Description
    Post-operative rehabilitation details
    Time Frame
    6 weeks, 3 months, 6 months, 12 months, 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer N Jennings
    Phone
    12027423861
    Email
    JJennings@mcra.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Scheker
    Organizational Affiliation
    Aptis Medical
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.

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