Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, post-traumatic arthritis
Treatment ascension® mcp finger implant
Sponsor Integra LifeSciences Corporation
Start date February 2002
End date January 2020
Trial size 100 participants
Trial identifier NCT02408471, CP-MCP-002, NCT01398735

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single arm study, patient treated with Ascension® PyroCarbon MCP implant.
ascension® mcp finger implant
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Primary Outcomes

Measure
Rate of revision
time frame: One year

Secondary Outcomes

Measure
Improvement in joint range of motion from baseline
time frame: One year
Improvement in grip strength from baseline
time frame: One year
Improvement in patient satisfaction as measured by the visual analog scale
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Integra LifeSciences Corporation.