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

Smith & Nephew

Status: Terminated

Conditions: Osteoarthritis; Post-traumatic Arthritis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Device: Ascension® MCP Finger Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02408471

CP-MCP-002

Details and patient eligibility

About

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

Enrollment: 97 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Ascension® MCP Finger Implant

Other group

Description:

Single arm study, patient treated with Ascension® PyroCarbon MCP implant.

Treatment:

Device: Ascension® MCP Finger Implant