Overview

This trial is active, not recruiting.

Condition hallux rigidus
Treatments dorsal cheilectomy without amniotic membrane tissue implantation, dorsal cheilectomy with amniotic membrane tissue implantation
Phase phase 4
Sponsor OrthoCarolina Research Institute, Inc.
Start date April 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT01825356, 03-13-03A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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
(Experimental)
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

Primary Outcomes

Measure
American Orthopedic Foot and Ankle Society (AOFAS) score
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Principal investigator John K Ellington, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by OrthoCarolina Research Institute, Inc..