Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

Sponsor

OrthoCarolina Research Institute, Inc. (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01825356

Collaborator

(none)

Enrollment

Location

Arms

103.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hallux Rigidus	Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Actual Study Start Date :

Apr 8, 2013

Actual Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
Experimental: 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	Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

Experimental: 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

Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Outcome Measures

Primary Outcome Measures

American Orthopedic Foot and Ankle Society (AOFAS) score [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoCarolina	Charlotte	North Carolina	United States	28207

Sponsors and Collaborators

OrthoCarolina Research Institute, Inc.

Investigators

Principal Investigator: John K Ellington, MD, OrthoCarolina Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

OrthoCarolina Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT01825356

Other Study ID Numbers:

03-13-03A

First Posted:

Apr 5, 2013

Last Update Posted:

Sep 18, 2020

Last Verified:

Sep 1, 2020

Additional relevant MeSH terms:

Hallux Rigidus

Hallux Limitus

Study Results

No Results Posted as of Sep 18, 2020