Prospective Trial of Minimally Invasive Surgery Versus Standard Surgery for Correction of Hallux Valgus (Minibunion)
Hallux Valgus
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years old
- Patients with mild to moderate hallux valgus which has been unresponsive to nonoperative measures. Mild to moderate hallux valgus deformity is defined by weightbearing xray-findings of a hallux valgus angle of greater than normal (< 15°) and less than 39°, and a intermetatarsal angle less than 18°.
- Patients who are willing to be randomized to either of the surgical procedures.
- Patients who are able to understand and sign the consent form
- Patients who are able to understand and complete the study questionnaires
- Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the active participation period (12 weeks).
Exclusion Criteria:
- Patients who have had previous bunion surgery on the affected foot
- Patients who have symptomatic arthritis of the metatarsophalangeal joint (hallux rigidus).
- History of systemic inflammatory condition or infection of the great toe or nearby soft tissues
- Diabetic or neuropathic Charcot arthropathy
- Significant vascular insufficiency
- Factors which unacceptably increase the risk of surgical complications
Sites / Locations
- Newton Wellesley HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
conventional surgery arm
minimally invasive technique
The conventional surgical technique is a Chevron-type distal metatarsal osteotomy, which is performed through a dorsomedial incision approximately 7 cm long. And osteotomy of the distal portion of the first metatarsal is made. The capital or distal fragment of the metatarsal is mobilized and displaced laterally an adequate amount to correct the hallux valgus deformity. The capital or distal fragment is stabilized in corrected position with screws.
The minimally invasive surgical technique is a transverse subcapital distal metatarsal osteotomy, which is performed through a direct medial incision approximately 1 cm long. The osteotomy of the distal portion of the first metatarsal is made using fluoroscopic image guidance. The capital or distal fragment of the metatarsal is mobilized and displaced laterally an adequate amount to correct the hallux valgus deformity. A 2.0 mm Kirschner wire is placed percutaneously in a position medial to the proximal phalanx, and advanced proximally using fluoroscopic guidance until the proximal end of the wire is located in a stable position within the medullary cavity of the first metatarsal