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Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2) (GRIP 2)

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ClinicalTrials.gov Identifier: NCT03247439
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cartiva, Inc.

Brief Summary:
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the first CMC joint in the hand compared to LRTI.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Cartiva Not Applicable

Detailed Description:

This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC.

A total of 74 subjects will be enrolled into the pivotal study.

Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Osteoarthritis

Arm Intervention/treatment
Experimental: Cartiva
Synthetic Cartilage Implant
Device: Cartiva
Synthetic Cartilage Implant




Primary Outcome Measures :
  1. Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year ]
    Visual Analog Scale (VAS) Pain

  2. Function measured by QuickDASH [ Time Frame: 1 year ]
    QuickDASH functional score

  3. Radiographic Findings [ Time Frame: 1 year ]
    Freedom from radiographic failures post-surgery

  4. Safety [ Time Frame: 1 year ]
    Freedom from Subsequent Secondary Surgical Interventions



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 22 years of age
  • Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention
  • Eaton classification stage II or III OA of the first CMC joint based on X-rays taken within 6 months of the Operative date and evidence of first CMC joint OA based on subjective review of associated clinical symptoms
  • Be willing and able to return for all study-related follow up procedures

Exclusion Criteria:

  • Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
  • History of or current diagnosis of rheumatoid arthritis
  • OA of the scaphotrapeziotrapezoidal (STT) joint based on radiographic assessment in the hand to be treated
  • Any disease, including uncontrolled diabetes mellitus, which is clinically known to impact wound healing ability
  • Known or suspected allergic reaction to polyvinyl alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247439


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92093
United States, Georgia
Georgia Hand, Shoulder & Elbow
Atlanta, Georgia, United States, 30309
United States, Indiana
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Hospital for Specialty Surgery
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14642
United Kingdom
Royal Derby Hospital
Derby, Derbyshire, United Kingdom, DE22 3NE
Dorset County Hospital
Dorchester, Dorset, United Kingdom, DT2 8DH
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
South Tees Hospitals
Middlesborough, North Yorkshire, United Kingdom, TS4 3BW
Sponsors and Collaborators
Cartiva, Inc.
Investigators
Principal Investigator: Scott Wolfe, MD Hospital for Special Surgery, New York

Responsible Party: Cartiva, Inc.
ClinicalTrials.gov Identifier: NCT03247439     History of Changes
Other Study ID Numbers: PTC-0290
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Cartiva, Inc.:
CMC Joint
Osteoarthritis
Cartilage Replacement
First CMC Joint Osteoarthritis
Damaged Articular Surface
LRTI
Ligament Reconstruction Tendon Interposition

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases