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NCT01825356 · ClinicalTrials.gov registry record · Phase 4
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
A Phase 4 study of Hallux Rigidus, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01825356 is a Phase 4 study of Hallux Rigidus that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01825356, a Phase 4 study of Hallux Rigidus, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation
- PROCEDURE Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation
Study Locations (1)
North Carolina
- OrthoCarolina - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-04-08 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01825356
The ClinicalTrials.gov registry entry for NCT01825356 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrthoCarolina Research Institute, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hallux Rigidus appearing as the primary indexed condition, and to 2 interventions - of which Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation is the first listed.
NCT01825356 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01825356 about?
NCT01825356 is a clinical study titled "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 Orthope...
What is the current status of trial NCT01825356?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2013-04-08. Estimated completion is 2020-11-10.
What conditions does trial NCT01825356 study?
This clinical trial studies the following conditions: Hallux Rigidus.
What interventions are being tested in trial NCT01825356?
The interventions under investigation include: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation (PROCEDURE), Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation (PROCEDURE).
Who is sponsoring clinical trial NCT01825356?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01825356 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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