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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2015-01-31

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis Systemic Lupus Erythematosus Osteoarthritis Post-traumatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ascension® MCP Finger Implant

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

Group Type OTHER

Ascension® MCP Finger Implant

Intervention Type DEVICE

Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Interventions

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Ascension® MCP Finger Implant

Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No