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

Cartiva

Status

Unknown

Conditions

Osteoarthritis

Treatments

Device: Cartiva

Study type

Interventional

Funder types

Industry

Identifiers

NCT03247439

PTC-0290

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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