Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2018 |
| Start Date: | April 8, 2013 |
| End Date: | February 28, 2019 |
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.
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.
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
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