Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
Inclusion Criteria
- 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
- 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
- Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
Exclusion Criteria
- Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
- Patients that use ambulatory assistive devices
- ...
- Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
- Patients that use ambulatory assistive devices
- Patients with systemic inflammtory arthritis
- < 18 years of age
Summary
- Conditions
- Hallux Rigidus
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- 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
- 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
- Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
Exclusion Criteria
- Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
- Patients that use ambulatory assistive devices
- ...
- Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
- Patients that use ambulatory assistive devices
- Patients with systemic inflammtory arthritis
- < 18 years of age
Tracking Information
- NCT #
- NCT01825356
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John K Ellington, MD OrthoCarolina Research Institute, Inc.
- John K Ellington, MD OrthoCarolina Research Institute, Inc.
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