Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus | NCT01825356

Studies
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

NCT01825356

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Completed

Last Update Posted

Feb 9, 2023Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Hallux Rigidus

Interventions

Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2013Actual

Primary Completion Date

Sep 2019Actual

Completion Date

Nov 10, 2020Actual

First Submitted Date

Apr 2, 2013

First Submission Date that Met QC Criteria

Apr 4, 2013

First Posted Date

Apr 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation	Active Comparator	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
Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation	Procedure		Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American Orthopedic Foot and Ankle Society (AOFAS) score		6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John K Ellington, MD	OrthoCarolina Research Institute, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina		Charlotte	North Carolina	28207	United States

Condition Browse Module

MeSH Terms

ID	Term
D020859	Hallux Rigidus

Ancestor Terms

ID	Term
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

Browse Leaves

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Browse Branches

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