Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

NCT01825356 | Completed Phase 4 DMC

• 1 other identifier: 03-13-03A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Rigidus

Outcome Measures

Primary Outcomes (1)

• American Orthopedic Foot and Ankle Society (AOFAS) score

  6 Months

Study Arms (2)

Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation

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.

Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

Dorsal Cheilectomy-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

Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Interventions

Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation PROCEDURE

Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation

Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation PROCEDURE

Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Study Officials

• John K Ellington, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: April 8, 2013
• Primary Completion: September 1, 2019
• Study Completion: November 10, 2020
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

US (1)