Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

Completed · Phase 4

Conditions studied: Hallux Rigidus

In brief

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.

Key facts

Study ID

NCT01825356

Run by

OrthoCarolina Research Institute, Inc.

People needed

60

Starts

2013-04-08

Expected to finish

2020-11-10

Last updated by the study team

2023-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• OrthoCarolina — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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