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Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
Phase 4
Waitlist Available
Led By John K Ellington, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial is testing whether adding amniotic membrane tissue to a common procedure for treating arthritis in the big toe joint results in better clinical and functional outcomes for patients.
Eligible Conditions
- Hallux Rigidus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dorsal Cheilectomy-Amniotic Membrane Tissue ImplantationExperimental Treatment1 Intervention
Dorsal cheilectomy procedure with the addition of the amniotic membrane. Amniotic membrane represents a biologic therapy that has the ability to actively regulate myrofibroblast formation and activity within the joint space and surgical site
Group II: Dorsal Cheilectomy no Amniotic Membrane Tissue ImplantationActive Control1 Intervention
Dorsal cheilectomy is a surgery for hallux rigidus(degenerative arthritis and stiffness due to bone spurs that affect the joint at the base of the big toe). No amniotic membrane will be used for this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
2013
Completed Phase 4
~60
Find a Location
Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
36 Previous Clinical Trials
5,986 Total Patients Enrolled
John K Ellington, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.