Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

Hallux Rigidus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825356
• Other study ID #: 03-13-03A
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2013
• Est. completion date: November 10, 2020

Study information

• Verified date: February 2023
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 10, 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Procedure:
• Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

• Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Society (AOFAS) score		6 Months