Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

Study Overview
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Brief Summary
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This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.

Official Title
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Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

Conditions
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Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis

Intervention / Treatment
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* Device: Ascension® MCP Finger Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indications consistent with the FDA approved Indications For Use: Index, long, ring, or small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization Willing to participate in the study Signed an Informed Consent Form The means and ability to return for all required study visits Are not transient Exclusion Criteria: Patients who have any of the following contraindications will be excluded from the study: Inadequate bone stock at the implantation site Active infection in the MCP joint Nonfunctioning and irreparable MCP musculotendinous system Physical interference with or by other prostheses during implantation or use Procedures requiring modification of the prosthesis Skin, bone, circulatory and/or neurological deficiency at the implantation site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ascension® MCP Finger Implant<br>Single arm study, patient treated with Ascension® PyroCarbon MCP implant. | Device: Ascension® MCP Finger Implant<br>* Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Revisions | Count of participants with a revision surgery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Joint Range of Motion | Range of motion measured by clinical assessment for joint extension and joint flexion. Measurements of extension and flexion made and recorded to the nearest degree using a goniometer with the wrist in the neutral position. Extension measured with fingers actively extended and flexion measured after the participant made a fist. | Preoperatively to 12 months | 
| Change in Radial-Ulnar Deviation | Measurements of ulnar deviation made for each implanted metacarpophalangeal (MCP) joint. Measurements made to the nearest degree using a goniometer with the participant's wrist in a neutral position and the finger(s) fully extended (e.g., no extension deficit). Radial deviation or ulnar deviation direction checked. | Preoperatively to 12 months | 
| Change in Tip Pinch | Quantitative measurements of opposition tip pinch strength was made for each implanted digit. Measurements made using a pinch meter. For each strength measurement, the participant made 3 attempts with the maximum value recorded. If the participant could not perform the pinch test due to inflammation, excessive pain, or some other reason, DNA (which stands for Did Not Attempt) was recorded. If the participant performs the pinch test but cannot register significant load, the value zero (0) was recorded. | Preoperatively to 12 months | 
| Change in Grip Strength | Implanted hand grip strength measured using a grip dynamometer instrument. | Preoperatively to 12 months | 
| Function Visual Analog Scale (VAS) | VAS Function based on a scale of 0 to 100 as completed by the participant with 0 indicating worse function and 100 indicating normal function | Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months | 
| Joint Pain Visual Analog Score (VAS) | VAS Joint Pain based on a scale of 0 to 100 as completed by the participant with 0 indicating no pain and 100 indicating severe pain. | Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months | 
| Cosmetic Appearance Visual Analog Scale (VAS) | VAS Cosmetic Appearance based on a scale of 0 to 100 as completed by the participant with 0 indicating worst appearance and 100 indicating normal appearance. | Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months | 
| Joint Position | Joint position for the affected finger determined by radiographic evaluation. Standard anteroposterior (AP), oblique, and lateral radiographs were made at the pre-operative and all post-operative evaluation visits of the hand(s) in which the Ascension MCP device was implanted. Joint position was classified as reduced, subluxed, dislocated, or (data) missing. | Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months | 
| Component Migration | Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing. | 6 Weeks, 12 Weeks, 6 Months, 12 Months | 
| Bone Changes by Device | X-rays were examined to determine if the implant components demonstrate stable fixation in the bone. Bone changes were classified as no changes (i.e., none), any bone changes, or (data) missing. | 6 Weeks, 12 Weeks, 6 Months, 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases