Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Hallux Rigidus

Treatments: Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation; Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01825356

03-13-03A

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation

Active Comparator group

Description:

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.

Treatment:

Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation

Experimental group

Description:

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

Treatment:

Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation