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

NCT02408471 | Terminated Results DMC

• 1 other identifier: CP-MCP-002
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

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

Keywords

Arthritis; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Osteoarthritis; Autoimmune Diseases; Connective Tissue Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Revisions

  Count of participants with a revision surgery.

  12 months

Secondary Outcomes (10)

• Change in Joint Range of Motion

  Preoperatively to 12 months

• Change in Radial-Ulnar Deviation

  Preoperatively to 12 months

• Change in Tip Pinch

  Preoperatively to 12 months

• Change in Grip Strength

  Preoperatively to 12 months

• Function Visual Analog Scale (VAS)

  Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months

Study Arms (1)

Ascension® MCP Finger Implant

OTHER

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

Device: Ascension® MCP Finger Implant

Interventions

Ascension® MCP Finger Implant DEVICE

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

Ascension® MCP Finger Implant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (9)

Southwest Shoulder Elbow and Hand Center, P.C.

Tucson, Arizona, 85712, United States

Location

Bloomington Bone and Joint Clinic

Bloomington, Indiana, 47403, United States

Location

Reconstructive Hand Surgeons of Indiana

Carmel, Indiana, 46032, United States

Location

The Indiana Hand Center

Indianapolis, Indiana, 46260, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

The Center for Ortho/ Neuro Care & Research

Bend, Oregon, 97701, United States

Location

ROC Houston, PA

Houston, Texas, 77004, United States

Location

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

Location

The Hand Center of San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Osteoarthritis; Arthritis; Autoimmune Diseases; Connective Tissue Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Limitations and Caveats

Study early terminated by Integra LifeSciences due to poor follow-up.

Results Point of Contact

• Title: Belinda Larson, Director, Global Clinical Strategy (Trauma)
• Organization: Smith+Nephew, Inc.

belinda.larson@smith-nephew.com

Study Officials

• Andrew Tummon

  Sponsor- Integra LifeSciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: April 3, 2015
• Study Start: June 1, 2002
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2017-08

Locations

US (9)