Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

Phase 4

Completed

• Conditions: Hallux Rigidus
• Interventions: Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation; Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

• Registration Number: NCT01825356
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Study Start: 2013-04-08
• Primary Completion: 2019-09
• Study Completion: 2020-11-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation	Dorsal Cheilectomy without 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-Amniotic Membrane Tissue Implantation	Dorsal Cheilectomy with 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

Primary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society (AOFAS) score	6 Months

Trial Locations

Locations (1)

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States