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OpenTrials
Completed

NCT Number: NCT01825356

Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

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.

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Key information

Conditions

Hallux Rigidus Foot Deformities Foot Deformities, Acquired Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation

Procedure

Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Procedure

Primary outcomes

  1. American Orthopedic Foot and Ankle Society (AOFAS) score

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Apr 5, 2013
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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