Status:
NOT_YET_RECRUITING
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Lead Sponsor:
St. Paul's Hospital, Canada
Collaborating Sponsors:
Stryker Nordic
Conditions:
Hallux Valgus and Bunion
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a ne...
Eligibility Criteria
Inclusion
- The subject is at least 19 years of age.
- The subject is considered to be skeletally mature.
- The subject is undergoing an isolated 1st TMT, which may or may not include concomitant procedures, such as:
- Soft tissue realignment
- Heel cord lengthening
- Akin osteotomy
- Lesser toe osteotomies or claw toe correction
- The subject is able to comply with all post-operative evaluations and visits.
- The subject is able to provide informed consent.
- The subject consents to and will receive either arthroscopy or no arthroscopy condition using the PROstep MIS 5mm Chamfer Screw.
Exclusion
- Patients indicated for TMT fusion for non-hallux valgus procedures.
- Patients with simultaneous fusion of second and third ray.
- Patients indicated for navicular-cuneiform joint performed at the same time.
- The subject has:
- Arthritis in the affected joint
- Severe osteoporosis
- Neuromuscular impairment
- Prior or current infection in the affected joint
- Charcot foot
- The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt).
- The subject will be undergoing an ankle replacement, any other concomitant fusion(s), or any lesser metatarsal osteotomies in the affected foot or ankle in the same sitting.
- The subject has concomitant injury, which in the opinion of the Investigator, is likely to impair functions for as long as or longer than the recovery from the subject's 1st TMT fusion.
- The subject is deemed morbidly obese (BMI \> 50 kg/m2
- The subject has a major risk factor for non-union (ex. poorly controlled diabetes, current smoker).
- There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion. The patient currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.
- The subject is known to be pregnant during the study period.
- The Investigator judges the subject to be unable or unlikely to remain compliant to follow-up due to a physical or mental condition (ex. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.).
- The subject is unable to provide informed consent.
- The subject is unable to communicate with the research team.
- The subject is unable to comply with follow-up.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06570590
Start Date
October 1 2024
End Date
May 1 2027
Last Update
August 26 2024
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6