Ascension® MCP Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ascension Orthopedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Ascension Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT01398735
First received: July 19, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Osteoarthritis
Post-traumatic Arthritis
Device: Ascension MCP Finger Implant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ascension® MCP Finger Implant Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Ascension Orthopedics, Inc.:

Primary Outcome Measures:
  • The effect of rehabilitation therapy protocol [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The study is being conducted to evaluate the effect of the revised rehabilitation therapy protocol within the 12-month post-operative period.


Secondary Outcome Measures:
  • Safety and Effectiveness [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Patients will be assessed to collect data related to safety and effectiveness endpoints at the following intervals: surgery/immediate post-op, 6 weeks, 12 weeks, 6 months, and 12 months.


Estimated Enrollment: 100
Study Start Date: February 2002
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCP implant
Single arm study, patient treated with Ascension Pyrocarbon MCP implant.
Device: Ascension MCP Finger Implant
Patients who meet inclusion/exclusion criteria are treated with the Ascension MCP.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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; and
  • 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; or
  • Skin, bone, circulatory and/or neurological deficiency at the implantation site.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398735

Contacts
Contact: Candi Langmaid, MPH 512-852-3935 candi.langmaid@integralife.com

Locations
United States, Arizona
Southwest Shoulder, Elbow and Hand Center Active, not recruiting
Tucson, Arizona, United States, 85712
United States, Indiana
Bloomington Bone and Joint Clinic Recruiting
Bloomington, Indiana, United States, 47403
Contact: Dale Dellacqua, M.D.    812-333-4000      
Contact: Audrey Edwards    812-333-4000      
Principal Investigator: Dale Dellacqua, M.D.         
Reconstructive Hand Surgeons of Indiana Completed
Carmel, Indiana, United States, 46032
Indiana Hand Center Completed
Indianapolis, Indiana, United States, 46260
United States, Minnesota
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
United States, Oregon
The Center Recruiting
Bend, Oregon, United States, 97701
Contact: James R. Verheyden, M.D.    541-330-8653      
Contact: Meredith Dawson, R.N.    541- 330-8653      
Principal Investigator: James R. Verheyden, M.D.         
United States, Texas
Fondren Orthopedic Group Recruiting
Houston, Texas, United States, 77030
Contact: James B. Bennett, M.D.    713-799-2300      
Contact: Susan Ball, R.N.    713-799-2300      
Principal Investigator: James B. Bennett, M.D.         
Park Plaza Hospital and Medical Center Not yet recruiting
Houston, Texas, United States, 77004
Contact: Zola Lander, B.S.N.    713-527-5027    ZOLA.LANDER@tenethealth.com   
Principal Investigator: Marcos Masson, M.D.         
Hand Center of San Antonio Withdrawn
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Ascension Orthopedics, Inc.
  More Information

No publications provided

Responsible Party: Ascension Orthopedics, Inc.
ClinicalTrials.gov Identifier: NCT01398735     History of Changes
Other Study ID Numbers: CP-MCP-002
Study First Received: July 19, 2011
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascension Orthopedics, Inc.:
revised rehabilitation therapy protocols
safety and effectiveness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014