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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT02408471
First received: November 4, 2014
Last updated: March 31, 2015
Last verified: March 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Rate of revision [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in joint range of motion from baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
    Range of motion measured by clinical assessment

  • Improvement in grip strength from baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
    Grip strength measured by dynometer

  • Improvement in patient satisfaction as measured by the visual analog scale [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2002
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ascension® MCP Finger 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
  • 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
  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: NCT02408471

Locations
United States, Arizona
Southwest Shoulder Elbow and Hand Center, P.C.
Tucson, Arizona, United States, 85712
United States, Indiana
Bloomington Bone and Joint Clinic
Bloomington, Indiana, United States, 47403
Reconstructive Hand Surgeons of Indiana
Carmel, Indiana, United States, 46032
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Oregon
The Center for Ortho/ Neuro Care & Research
Bend, Oregon, United States, 97701
United States, Texas
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States, 77030
ROC Houston, PA
Houston, Texas, United States, 77004
The Hand Center of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Study Director: Candi Langmaid, MPH Sponsor- Integra LifeSciences
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT02408471     History of Changes
Obsolete Identifiers: NCT01398735
Other Study ID Numbers: CP-MCP-002
Study First Received: November 4, 2014
Last Updated: March 31, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Integra LifeSciences Corporation:
Arthritis
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on July 01, 2015