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

NCT01602926 | Unknown

• 1 other identifier: P2012-Minibunion
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

hallux valgus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months from date of surgery

Secondary Outcomes (1)

• 2 weeks preoperative to 12 weeks postoperative change in hallux valgus angle (HVA).

  12 weeks

Study Arms (2)

conventional surgery arm

EXPERIMENTAL

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

minimally invasive technique

EXPERIMENTAL

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

Interventions

conventional surgical technique - Chevron-type distal metatarsal osteotomy PROCEDURE

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.

conventional surgery arm

minimally invasive surgical technique PROCEDURE

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 technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Henry DeGroot, M.D.: lead

Study Sites (1)

Newton Wellesley Hospital

Newton, Massachusetts, 02459, United States

RECRUITING

Related Publications (5)

• Smith SE, Landorf KB, Butterworth PA, Menz HB. Scarf versus chevron osteotomy for the correction of 1-2 intermetatarsal angle in hallux valgus: a systematic review and meta-analysis. J Foot Ankle Surg. 2012 Jul-Aug;51(4):437-44. doi: 10.1053/j.jfas.2012.02.016. Epub 2012 Apr 8.

  PMID: 22487651 BACKGROUND

• Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.

  PMID: 20710024 BACKGROUND

• Oliva F, Longo UG, Maffulli N. Minimally invasive hallux valgus correction. Orthop Clin North Am. 2009 Oct;40(4):525-30, x. doi: 10.1016/j.ocl.2009.06.005.

  PMID: 19773058 BACKGROUND

• Ferrari J, Higgins JP, Prior TD. WITHDRAWN: Interventions for treating hallux valgus (abductovalgus) and bunions. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD000964. doi: 10.1002/14651858.CD000964.pub3.

  PMID: 19370560 BACKGROUND

• Deenik A, van Mameren H, de Visser E, de Waal Malefijt M, Draijer F, de Bie R. Equivalent correction in scarf and chevron osteotomy in moderate and severe hallux valgus: a randomized controlled trial. Foot Ankle Int. 2008 Dec;29(12):1209-15. doi: 10.3113/FAI.2008.1209.

  PMID: 19138485 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Central Study Contacts

Henry DeGroot, MD

CONTACT

6177969923; degrootoffice@gmail.com

Maggie Gentile

CONTACT

6177969923; degrootoffice@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.I.

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 21, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2018
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

US (1)