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NCT01825356 Clinical Trial

Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

Hallux Rigidus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01825356
Other study ID # 03-13-03A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 8, 2013
Est. completion date November 10, 2020

Study information
Verified date February 2023
Source OrthoCarolina Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 outcomes compared to a standard dorsal cheilectomy procedure. 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 10, 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - < 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

• Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Locations
Country Name City State
United States OrthoCarolina Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary American Orthopedic Foot and Ankle Society (AOFAS) score 6 Months
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