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

Smith & Nephew, Inc.97 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis Systemic Lupus Erythematosus Osteoarthritis Post-traumatic Arthritis

Interventions

Ascension® MCP Finger ImplantDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (9)

Southwest Shoulder Elbow and Hand Center, P.C.

Tucson, Arizona, United States

Bloomington Bone and Joint Clinic

Bloomington, Indiana, United States

Reconstructive Hand Surgeons of Indiana

Carmel, Indiana, United States

Outcomes

Primary Outcomes

Number of Participants With Revisions

Count of participants with a revision surgery.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Preoperatively to 12 months

Change in Grip Strength

Implanted hand grip strength measured using a grip dynamometer instrument.

Time frame: Preoperatively to 12 months

Function Visual Analog Scale (VAS)

Data from ClinicalTrials.gov

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