Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
- Conditions
- Hallux Valgus and Bunion
- Registration Number
- NCT06570590
- Lead Sponsor
- St. Paul's Hospital, Canada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - The subject is at least 19 years of age.<br><br> - The subject is considered to be skeletally mature.<br><br> - The subject is undergoing an isolated 1st TMT, which may or may not include<br> concomitant procedures, such as:<br><br> - Soft tissue realignment<br><br> - Heel cord lengthening<br><br> - Akin osteotomy<br><br> - Lesser toe osteotomies or claw toe correction<br><br> - The subject is able to comply with all post-operative evaluations and visits.<br><br> - The subject is able to provide informed consent.<br><br> - The subject consents to and will receive either arthroscopy or no arthroscopy<br> condition using the PROstep MIS 5mm Chamfer Screw.<br><br>Exclusion Criteria:<br><br> - Patients indicated for TMT fusion for non-hallux valgus procedures.<br><br> - Patients with simultaneous fusion of second and third ray.<br><br> - Patients indicated for navicular-cuneiform joint performed at the same time.<br><br> - The subject has:<br><br> - Arthritis in the affected joint<br><br> - Severe osteoporosis<br><br> - Neuromuscular impairment<br><br> - Prior or current infection in the affected joint<br><br> - Charcot foot<br><br> - The subject has undergone previous fusion surgery of the proposed site (i.e.,<br> revision of failed fusion attempt).<br><br> - The subject will be undergoing an ankle replacement, any other concomitant<br> fusion(s), or any lesser metatarsal osteotomies in the affected foot or ankle in the<br> same sitting.<br><br> - The subject has concomitant injury, which in the opinion of the Investigator, is<br> likely to impair functions for as long as or longer than the recovery from the<br> subject's 1st TMT fusion.<br><br> - The subject is deemed morbidly obese (BMI > 50 kg/m2<br><br> - The subject has a major risk factor for non-union (ex. poorly controlled diabetes,<br> current smoker).<br><br> - There is radiographic evidence of bone cysts, segmental defects or growth plate<br> fracture around the fusion site that may negatively impact bony fusion. The patient<br> currently has untreated malignant neoplasm(s), or is currently undergoing radio- or<br> chemotherapy or has been diagnosed with hypercalcemia.<br><br> - The subject is known to be pregnant during the study period.<br><br> - The Investigator judges the subject to be unable or unlikely to remain compliant to<br> follow-up due to a physical or mental condition (ex. currently being treated for a<br> psychiatric disorder, senile dementia, Alzheimer's disease, etc.).<br><br> - The subject is unable to provide informed consent.<br><br> - The subject is unable to communicate with the research team.<br><br> - The subject is unable to comply with follow-up.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary: Bone Fusion
- Secondary Outcome Measures
Name Time Method Secondary: Questionnaires-Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS);Secondary: Questionnaires-Foot and Ankle Ability Measure (FAAM);Secondary: Questionnaires-Pain Catastrophizing Scale (PCS);Secondary: Re-operation and complication rates