Hallux RigidusPhase 4NCT01825356
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
A Phase 4 study testing Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation and Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation in people with Hallux Rigidus, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation and Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2013to 10 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation, Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Cheilectomy without Amniotic Membrane Tissue ImplantationProcedure or surgery
Dorsal Cheilectomy with Amniotic Membrane Tissue ImplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society (AOFAS) score
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start8 Apr 2013
- Primary completionSep 2019
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John K Ellington, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825356
- Sponsor's protocol ID
- 03-13-03A
- Status last verified
- Feb 2023
- First submitted
- 2 Apr 2013
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
- ClinicalTrials.gov ID
- NCT01825356
- Acronym / sponsor ID
- 03-13-03A
- Conditions
- Hallux Rigidus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 8 Apr 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation | Active comparator | Procedure: Dorsal Cheilectomy without Amniotic Membrane Tissue ImplantationDorsal 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. |
| Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation | Experimental | Procedure: Dorsal Cheilectomy with Amniotic Membrane Tissue ImplantationDorsal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation | Procedure or surgery | Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation |
| Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation | Procedure or surgery | Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation |
Primary outcome
American Orthopedic Foot and Ankle Society (AOFAS) score
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Ellington, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation and Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation in people with Hallux Rigidus, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle Society (AOFAS) score (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.