Randomized Prospective Trial of Minimally Invasive Surgery Versus Standard Surgery for Correction of Hallux Valgus.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Manchester-Oxford Foot Questionnaire Score (MOXFQ).
研究概览
简要总结
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.)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Manchester-Oxford Foot Questionnaire Score (MOXFQ).
时间窗: 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.
次要结局
- 2 weeks preoperative to 12 weeks postoperative change in hallux valgus angle (HVA).(12 weeks)