Cartiva for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arthrosis
Cartiva - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of Cartiva to LRTI for treating osteoarthritis of the first CMC joint in the hand.

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Function measured by QuickDASH
Key Subsequent Secondary Surgical Interventions (SSSIs)
Pain measured by the Visual Analog Scale (VAS) scale
Radiographic Findings

Trial Safety

Trial Design

1 Treatment Group

Cartiva
1 of 1

Experimental Treatment

74 Total Participants · 1 Treatment Group

Primary Treatment: Cartiva · No Placebo Group · N/A

Cartiva
Device
Experimental Group · 1 Intervention: Cartiva · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cartiva
2009
Completed Phase 3
~430

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Cartiva, Inc.Lead Sponsor
6 Previous Clinical Trials
493 Total Patients Enrolled
Scott Wolfe, MDPrincipal InvestigatorHospital for Special Surgery, New York
Christopher Bainbridge, MB ChB, FRCSEd, CCSTPrincipal InvestigatorRoyal Derby Hospital

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
s Lack of need for bone grafts is a desired outcome of any bone surgery.
The patient has 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 a subjective review of associated clinical symptoms.
The preoperative VAS pain score for the treated hand is ≥ 40.
You are at least 22 years old.
The text is about a person with a condition that has not improved with conservative treatment, and therefore requires surgery.
I’ve been told about the study, agreed to its requirements, and signed the informed consent form that was approved by the IRB/REB/Ethics Committee.
You are willing and able to return for all study-related follow-up procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%