What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include NSAIDs, glucocorticoid injections, and surgical interventions such as joint replacement. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and kidney problems. Glucocorticoid injections may lead to joint infection, increased pain, and tissue damage. Surgical interventions, including synthetic cartilage implants like Cartiva, can have risks such as infection, implant failure, and complications from anesthesia. Overall, while these treatments can provide symptomatic relief, they come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) and intraarticular glucocorticoid injections for pain relief. Additionally, the FDA has approved the use of chondrocyte transplantation techniques, such as the 'Carticel' approach, which involves synthesizing de novo cartilage from cultured chondrocytes. This method aims to restore joint function by replacing damaged cartilage, similar to the synthetic cartilage implant studied in the Cartiva trial.

What other types of research exist?

Promising novel alternatives to Cartiva for osteoarthritis treatment include: 1) Hydrogel-based medical implants, which are being explored for their potential in cartilaginous tissue regeneration. 2) Injectable poly-L-lactic acid (Sculptra), which has shown efficacy in soft tissue augmentation and may offer benefits for joint function restoration. 3) Intraarticular injections of recombinant human fibroblast growth factor (sprifermin), which have demonstrated potential in increasing cartilage depth, though further research is needed to confirm long-term efficacy and clinical relevance.

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Implant

Cartiva Implant for Hand Osteoarthritis (GRIP 2 Trial)

N/A

Waitlist Available

Led By Scott Wolfe, MD

Research Sponsored by Cartiva, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

≥ 22 years of age

Must not have

Active infection at the site of surgery

Active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if Cartiva, a small implant, can help people with thumb joint arthritis by reducing pain and improving movement. The study will follow patients over several years to see how well it works.

Who is the study for?

Adults over 22 with moderate osteoarthritis in the thumb joint, who haven't improved with standard non-surgical treatments for at least 6 months. Participants must have a certain level of pain and disability, good bone quality without significant loss or cysts, and be able to complete questionnaires. Excluded are those with infections, previous similar surgeries, inflammatory diseases like rheumatoid arthritis, recent cancer treatment affecting the arm, systemic diseases that could affect results or healing, current pregnancy or inadequate contraception use.

What is being tested?

The trial is testing if Cartiva—an implant—works better than a common surgical procedure called LRTI for treating thumb joint osteoarthritis. Patients will receive either Cartiva or undergo LRTI surgery and their outcomes will be compared to determine which is more effective in reducing pain and improving hand function.

What are the potential side effects?

Potential side effects may include infection at the surgery site, allergic reactions to materials in the implant (polyvinyl alcohol), complications from surgery such as poor wound healing especially in individuals with uncontrolled diabetes mellitus or other conditions known to impact healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thumb joint arthritis is at stage II or III, confirmed by recent X-rays.

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I am 22 years old or older.

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My hand arthritis hasn't improved with standard treatments for 6 months and needs surgery.

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My bones are strong and do not require a bone graft.

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My hand pain level is 40 or more on a scale of 0-100.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection where I had surgery.

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I am currently fighting an infection in my body.

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I have significant bone loss or a large cyst in my bones.

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I have osteoarthritis in a specific joint in my hand, confirmed by an X-ray.

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I was diagnosed with cancer within the last two years and treated with chemotherapy or radiation to my arm.

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I have a condition that affects my wound healing, like uncontrolled diabetes.

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I have a health condition that may shorten my life to under a year.

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I am not pregnant, planning to become pregnant, or breastfeeding, and if of childbearing age, I am using contraception.

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I am on long-term blood thinners or have taken them within 3 days before surgery.

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I do not have conditions that weaken my bones or prevent implants from being supported.

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I have had surgery on the joint that needs treatment.

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I have been diagnosed with inflammatory arthritis or gout.

Select...

I have been diagnosed with rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Function measured by QuickDASH

Key Subsequent Secondary Surgical Interventions (SSSIs)

Pain measured by the Visual Analog Scale (VAS) scale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CartivaExperimental Treatment1 Intervention

Synthetic Cartilage Implant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cartiva

2009

Completed Phase 3

~430

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Osteoarthritis (OA) include analgesics like acetaminophen, which reduce pain by inhibiting pain signals, and NSAIDs such as ibuprofen and naproxen, which reduce inflammation and pain by blocking COX enzymes. Glucocorticoids, administered orally or via intraarticular injections, provide short-term pain relief by reducing inflammation. Investigational treatments like BMP-7 and FGF-18 aim to repair cartilage and inhibit catabolic activities, potentially slowing disease progression. The Cartiva implant, a synthetic cartilage, replaces damaged cartilage to restore joint function and alleviate pain. These treatments are crucial for OA patients as they target pain relief, inflammation reduction, and joint function restoration, improving quality of life.

The Role of Bone Marrow Aspirate Concentrate for the Treatment of Focal Chondral Lesions of the Knee: A Systematic Review and Critical Analysis of Animal and Clinical Studies.Autologous tissue transplantations for osteochondral repair.