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

Not Applicable

Terminated

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

Interventions: Device: Ascension® MCP Finger Implant

Registration Number: NCT02408471

Lead Sponsor: Smith & Nephew, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 97

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ascension® MCP Finger Implant	Ascension® MCP Finger Implant	Single arm study, patient treated with Ascension® PyroCarbon MCP implant.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Revisions	12 months	Count of participants with a revision surgery.

Secondary Outcome Measures

Name	Time	Method
Change in Grip Strength	Preoperatively to 12 months	Implanted hand grip strength measured using a grip dynamometer instrument.
Change in Tip Pinch	Preoperatively to 12 months	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.
Function Visual Analog Scale (VAS)	Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months	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
Change in Joint Range of Motion	Preoperatively to 12 months	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.
Change in Radial-Ulnar Deviation	Preoperatively to 12 months	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.
Joint Position	Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months	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.
Component Migration	6 Weeks, 12 Weeks, 6 Months, 12 Months	Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
Joint Pain Visual Analog Score (VAS)	Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months	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.
Cosmetic Appearance Visual Analog Scale (VAS)	Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months	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.
Bone Changes by Device	6 Weeks, 12 Weeks, 6 Months, 12 Months	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.

Trial Locations

Locations (9): Fondren Orthopedic Group, L.L.P.
🇺🇸
Houston, Texas, United States
Bloomington Bone and Joint Clinic
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Bloomington, Indiana, United States
Mayo Clinic Rochester
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Rochester, Minnesota, United States
Southwest Shoulder Elbow and Hand Center, P.C.
🇺🇸
Tucson, Arizona, United States
Reconstructive Hand Surgeons of Indiana
🇺🇸
Carmel, Indiana, United States
The Indiana Hand Center
🇺🇸
Indianapolis, Indiana, United States
ROC Houston, PA
🇺🇸
Houston, Texas, United States
The Center for Ortho/ Neuro Care & Research
🇺🇸
Bend, Oregon, United States
The Hand Center of San Antonio
🇺🇸
San Antonio, Texas, United States