Recruiting

Minimally Invasive Surgery vs. Standard Surgery

Sponsor:

Henry DeGroot, M.D.

Code:

NCT01602926

Conditions

Hallux Valgus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

conventional surgical technique - Chevron-type distal metatarsal osteotomy

minimally invasive surgical technique

minimally invasive surgical technique

Study Details

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: '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.)

Conditions

Hallux Valgus

Study ID

NCT01602926

Start date

Aug, 2012

Status verified date

Aug, 2012

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age > 18 years old
2. 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°.
3. Patients who are willing to be randomized to either of the surgical procedures.
4. Patients who are able to understand and sign the consent form
5. Patients who are able to understand and complete the study questionnaires
6. 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:

1. Patients who have had previous bunion surgery on the affected foot
2. Patients who have symptomatic arthritis of the metatarsophalangeal joint (hallux rigidus).
3. History of systemic inflammatory condition or infection of the great toe or nearby soft tissues
4. Diabetic or neuropathic Charcot arthropathy
5. Significant vascular insufficiency
6. Factors which unacceptably increase the risk of surgical complications

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: conventional surgery arm

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.

experimental: minimally invasive technique

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

Interventions

conventional surgical technique - Chevron-type distal metatarsal osteotomy

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 internal fixation screws used in the conventional surgical technique do not require removal.

minimally invasive surgical technique

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 (see figures) .The distal end of the Kirschner wire is left outside the skin where it is cut to length and covered. The Kirschner wire is removed after six weeks.

minimally invasive surgical technique

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Henry DeGroot, MD

6177969923degrootoffice@gmail.com

Maggie Gentile

6177969923degrootoffice@gmail.com

Locations

Newton Wellesley Hospital

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

Maggie Gentile

617-796-9922info@minibunion.com

Principal Investigator:

Henry DeGroot, MD

More Information

Sponsor

Henry DeGroot, M.D.

Last update posted

Aug 28, 2012

Last verified

Aug, 2012

Keywords

  • hallux valgus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry DeGroot, M.D. on 2012-08-28.