Prospective Trial of Minimally Invasive Surgery Versus Standard Surgery for Correction of Hallux Valgus

Status unconfirmed · Not applicable

Conditions studied: Hallux Valgus

In brief

Hallux valgus is a common deformity of the big toe, defined as medial deviation of the first metatarsal bone along with lateral deviation of the first toe. Surgery has been shown to be beneficial when compared to orthotics or no treatment. While generally effective, surgery is associated with significant post-operative pain and disability, with several weeks of limited mobility. Minimally invasive techniques have the potential to lead to increased patient satisfaction while still achieving adequate correction of the deformity. This trial is a non-inferiority treatment study, with open-label, randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of a minimally invasive surgery versus a conventional surgery for hallux valgus. This trial examines two different surgical interventions. No drug or device is being evaluated in this trial. 60 to 100 patients, over the age of 18 years, undergoing surgical correction of mild to moderate hallux valgus will be enrolled in the trial. The patients will be randomized to two groups, one treated with a conventional distal osteotomy surgery, the other treated with a minimally invasive surgery. Randomization will occur immediately prior to surgery via a multitude of opaque envelopes containing a coded group assignment. Due to the differences in the techniques, neither the investigator and the subject can be effectively blinded to the group assignment. Data collection for the outcomes measures will occur preop, and then post of at 2 weeks, 12 weeks, and at 1,2, and 3 years. The primary outcomes measure is the Manchester-Oxford Foot Questionnaire Score (MOXFQ). Manchester-Oxford Foot Questionnaire' (MOXFQ), a 16 item patient-reported questionnaire consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items) and 'Social interaction' (four items). The MOXFQ is a validated disease-specific outcomes scale for foot and ankle surgery which has been shown to be responsive and reliable. Secondary outcome measures are preoperative to postoperative change in hallux valgus angle (HVA). Radiographic outcomes parameters will be measured using weight-bearing radiographs to analyze preoperative and postoperative hallux valgus angle, and the correction or normalization thereof. (Degrees of correction = 2 week preoperative HVA - 12 week postoperative HVA.)

Key facts

Study ID: NCT01602926
Run by: Henry DeGroot, M.D.
People needed: 100
Starts: 2012-08-01
Expected to finish: 2018-09-01
Last updated by the study team: 2012-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Newton Wellesley Hospital — Newton, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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