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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Henry DeGroot, M.D.
Sponsor:
Information provided by (Responsible Party):
Henry DeGroot, Henry DeGroot, M.D.
ClinicalTrials.gov Identifier:
NCT01602926
First received: May 15, 2012
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.)


Condition Intervention
Hallux Valgus
Procedure: conventional surgical technique - Chevron-type distal metatarsal osteotomy
Procedure: minimally invasive surgical technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial of Minimally Invasive Surgery Versus Standard Surgery for Correction of Hallux Valgus.

Resource links provided by NLM:


Further study details as provided by Henry DeGroot, M.D.:

Primary Outcome Measures:
  • Manchester-Oxford Foot Questionnaire Score (MOXFQ). [ Time Frame: 12 months from date of surgery ] [ Designated as safety issue: No ]
    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:
  • 2 weeks preoperative to 12 weeks postoperative change in hallux valgus angle (HVA). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.)


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.
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
Procedure: 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.
Procedure: 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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602926

Contacts
Contact: Henry DeGroot, MD 6177969923 degrootoffice@gmail.com
Contact: Maggie Gentile 6177969923 degrootoffice@gmail.com

Locations
United States, Massachusetts
Newton Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02459
Contact: Maggie Gentile    617-796-9922    info@minibunion.com   
Principal Investigator: Henry DeGroot, MD         
Sponsors and Collaborators
Henry DeGroot, M.D.
  More Information

Publications:
Responsible Party: Henry DeGroot, P.I., Henry DeGroot, M.D.
ClinicalTrials.gov Identifier: NCT01602926     History of Changes
Other Study ID Numbers: P2012-Minibunion
Study First Received: May 15, 2012
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry DeGroot, M.D.:
hallux valgus

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014