NCT01825356

Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
PROCEDURE	Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Timeline

• Start date: 2013-04-08
• Primary completion: 2019-09-01
• Completion: 2020-11-10
• First posted: 2013-04-05
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States