Clinical trial NCT03247439: Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: CMC Joint
Osteoarthritis
Cartilage Replacement
First CMC Joint Osteoarthritis
Damaged Articular Surface
LRTI
Ligament Reconstruction Tendon Interposition
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 74
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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

Exclusion Criteria:

* 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
* Any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to, patients with a diagnosis of concomitant injury that may interfere with healing; patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease or systemic infection which may make interpretation of the results difficult; patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid in the thumb, antineoplastic, immunostimulating or immunosuppressive agents
* 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
* If female, be pregnant, planning to become pregnant during the course of the study, breast-feeding, or if childbearing age, is not using contraception
* Current or recent history of substance abuse (e.g., recreational drugs, narcotics, or alcohol) requiring intervention
* Is a prisoner or ward of the state
* Is unable to meet the treatment and follow up protocol requirements
* Is being compensated under workers' compensation or are currently involved in litigation that is related to the musculoskeletal system

Primary outcomes:
measure: Pain measured by the Visual Analog Scale (VAS) scale
timeFrame: 1 year
measure: Function measured by QuickDASH
timeFrame: 1 year
measure: Radiographic Findings
timeFrame: 1 year
measure: Key Subsequent Secondary Surgical Interventions (SSSIs)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Atlanta
country: United States
facility: Georgia Hand, Shoulder & Elbow
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: New York
country: United States
facility: Hospital for Specialty Surgery
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: Dorset
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
city: Middlesborough
country: United Kingdom
facility: South Tees Hospitals
state: North Yorkshire
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Scott Wolfe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Derby Hospital
name: Christopher Bainbridge, MB ChB, FRCSEd, CCST
role: PRINCIPAL_INVESTIGATOR
References: