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Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

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ClinicalTrials.gov Identifier: NCT01825356
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Hallux Rigidus Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : April 8, 2013
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Active Comparator: Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation
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.
Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
Experimental: Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation
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
Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation



Primary Outcome Measures :
  1. American Orthopedic Foot and Ankle Society (AOFAS) score [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825356


Locations
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United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
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Principal Investigator: John K Ellington, MD OrthoCarolina Research Institute, Inc.

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01825356     History of Changes
Other Study ID Numbers: 03-13-03A
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
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Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries