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

NCT03247439 | Unknown DMC FDA Device

• 1 other identifier: PTC-0290
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 9

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.

Conditions

Osteoarthritis

Keywords

CMC Joint; Osteoarthritis; Cartilage Replacement; First CMC Joint Osteoarthritis; Damaged Articular Surface; LRTI; Ligament Reconstruction Tendon Interposition

Outcome Measures

Primary Outcomes (4)

• Pain measured by the Visual Analog Scale (VAS) scale

  Success criteria: ≥ 30% VAS decrease at 12 months. Visual Analog Scale (VAS) Pain score will be obtained from the subject for pain in the treated hand by completing a CRF, which has a 100 mm horizontal line on it, with the left end indicating that the subject has no pain and the right end of the line indicating a lot of pain. The subject will be instructed to place a mark on the horizontal line to rate the average pain in the treated thumb joint over the past week. The designated site staff will use a metric ruler to measure the markings made by the subject on the VAS to determine the VAS score.

  1 year

• Function measured by QuickDASH

  Success criteria: ≥ 15.9 point decrease at 12 months. QuickDASH functional score will be obtained from the subject. The QuickDASH, the shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcomes Measures, is a region-specific, self-reported questionnaire that uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Subjects are asked to circle the appropriate response to each question based on their condition in the past week.

  1 year

• Radiographic Findings

  Success criteria: Freedom from radiographic failures post-surgery through 12 months. Radiographic failures are defined as device dislocation, device fragmentation and/or development of avascular necrosis.

  1 year

• Key Subsequent Secondary Surgical Interventions (SSSIs)

  Success criteria: Freedom from Subsequent Secondary Surgical Interventions (SSSIs) through 12 months. SSSIs are defined as revisions, removals, reoperations, and/or supplemental fixations.

  1 year

Study Arms (1)

Cartiva

EXPERIMENTAL

Synthetic Cartilage Implant

Device: Cartiva

Interventions

Cartiva DEVICE

Synthetic Cartilage Implant

Cartiva

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• Preoperative VAS Pain score of ≥ 40 in the treated hand
• Preoperative 11 question QuickDASH score of ≥ 20
• Presence of good bone stock - i.e., no need for bone graft
• Capable of completing self-administered questionnaires
• Be willing and able to return for all study-related follow up procedures
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/REB/Ethics Committee

You may not qualify if:

• Active systemic infection
• Active infection at the site of surgery
• Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
• Inflammatory arthropathy and/or diagnosis of grout
• History of or current diagnosis of rheumatoid arthritis
• Any significant bone loss, avascular necrosis, or cyst \> 8mm of the supporting bone structure
• Eaton classification stage IV advanced OA of the first CMC joint based on X-rays taken within 6 months of the Operative date
• Physical conditions that would tend to eliminate adequate implant support (e.g., inadequate cortical bone stock of at least 2mm circumferentially insufficient quality or quantity of bone resulting from cancer, congenital dislocation, or osteoporosis), systemic and metabolic disorders leading to progressive deterioration of bone (e.g., cortisone therapies or immunosuppressive therapies), and/or tumors and/or cysts of the supporting bone structures
• 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
• Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 3 days prior to surgery
• Diagnosed with cancer in the last two years and received treatment with chemotherapy or received radiation to the upper extremity to be treated with Cartiva
• Have participated in any other investigational or invasive clinical trial within the last three months, and will not participate in any other investigational or invasive clinical trial during this study
• Co-morbidity that reduces life expectancy to less than 12 months

Sponsors & Collaborators

• Cartiva, Inc.: lead

Study Sites (9)

University of California, San Diego

San Diego, California, 92093, United States

Location

Georgia Hand, Shoulder & Elbow

Atlanta, Georgia, 30309, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46202, United States

Location

Hospital for Specialty Surgery

New York, New York, 10021, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Dorset County Hospital

Dorchester, Dorset, DT2 8DH, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

South Tees Hospitals

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Scott Wolfe, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Christopher Bainbridge, MB ChB, FRCSEd, CCST

  Royal Derby Hospital

  PRINCIPAL INVESTIGATOR

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: August 4, 2017
• First Posted: August 11, 2017
• Study Start: December 22, 2017
• Primary Completion: October 30, 2020
• Study Completion: March 1, 2024
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); GB (4)