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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Prospective Trial of Minimally Invasive Surgery Versus Standard Surgery for Correction of Hallux Valgus.

Brief Summary:

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:

Detailed Summary:

Randomized prospective trial of minimally invasive surgery versus standard surgery for correction of hallux valgus.

Introduction

It is estimated that more than 200,000 hallux valgus surgeries are performed each year in the United States. [1] More than 100 procedures have been described for correction of hallux valgus.[2] Considerable controversy remains over the best technique.

Recently, a number of minimally invasive techniques for correction of hallux valgus have been described. [3, 5, 6]. These minimally invasive techniques emphasize less traumatic surgical exposure and more limited dissection of the soft tissues. It has been proposed that minimally invasive procedures lead to less pain, decreased swelling, shorter recovery times and more rapid return to full weightbearing activities. Not all reports have been positive, and some authors report an increased number of complications, including loss of correction and malposition of the bones [7].

Minimally invasive treatment of hallux valgus is becoming increasingly common in podiatric and orthopedic clinical practice, due to the theoretical advantages of more rapid recovery, more rapid return to full activities, and decreased pain. These techniques have the potential advantage of providing better clinical outcomes and having lower cost.

An increasing number of research publications on this topic have appeared in recent years, which reflects both growing interest and development in this field amongst foot and ankle surgeons. However, despite the increasing interest, there are no high-quality studies of these procedures available. In a 2011 systematic review [8], 24 publications describing the outcomes of minimally invasive hal
Sponsor: Henry DeGroot, M.D.

Current Primary Outcome: Manchester-Oxford Foot Questionnaire Score (MOXFQ). [ Time Frame: 12 months from date of surgery ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 2 weeks preoperative to 12 weeks postoperative change in hallux valgus angle (HVA). [ Time Frame: 12 weeks ]

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 = preoperative HVA - 12 week postoperative HVA.)


Original Secondary Outcome: Same as current

Information By: Henry DeGroot, M.D.

Dates:
Date Received: May 15, 2012
Date Started: August 2012
Date Completion: September 2018
Last Updated: August 24, 2012
Last Verified: August 2012