Ascension® MCP Post-Approval Study
This study is currently recruiting participants.
Verified October 2012 by Ascension Orthopedics, Inc.
Sponsor:
Ascension Orthopedics, Inc.
Information provided by (Responsible Party):
Ascension Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT01398735
First received: July 19, 2011
Last updated: October 2, 2012
Last verified: October 2012
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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: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398735
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: | October 2, 2012 |
| 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 May 19, 2013