Status:
COMPLETED
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Conditions:
Hallux Rigidus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy procedure with implementation of amniotic membrane tissue results in improved clinical and functional outcome...
Eligibility Criteria
Inclusion
- Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
- Patients over the age of 18 able to consent to participate
- The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Exclusion
- \< 18 years of age
- Patients that use ambulatory assistive devices
- Patients with systemic inflammtory arthritis
- Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
Key Trial Info
Start Date :
April 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01825356
Start Date
April 8 2013
End Date
November 10 2020
Last Update
February 9 2023
Active Locations (1)
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1
OrthoCarolina
Charlotte, North Carolina, United States, 28207