Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
NCT ID: NCT01825356
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2013-04-08
2020-11-10
Brief Summary
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Specific Aim 1:
To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.
Specific Aim 2:
To compare range of motion between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane tissue will demonstrate less postoperative stiffness as measured from the pre-and postoperative radiographs.
Specific Aim 3:
To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation
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.
Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation
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
Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
Interventions
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Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
Eligibility Criteria
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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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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OrthoCarolina Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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John K Ellington, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoCarolina Research Institute, Inc.
Locations
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OrthoCarolina
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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03-13-03A
Identifier Type: -
Identifier Source: org_study_id
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