Clinical Trial: Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy: a Longitudinal Prospective Study With

Brief Summary: Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate radiographic and functional outcomes in patients with mild-to-severe HV who underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.

Detailed Summary: Eighty patients with mild-to-severe symptomatic HV were treated by MIS. Clinical evaluation was assessed pre-operatively, as well as at 3 and 12 months after surgery and at final follow-up of 48 months, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux grading system. Patient satisfaction and complications were recorded. Computer-assisted measurement of antero-posterior radiographs was taken pre-operatively, as well as at 3 and 12 months after surgery and at 48-month follow-up, analysing the intermetatarsal angle (IMA), the hallux valgus angle (HVA), the distal metatarsal articular angle (DMAA), and the tibial sesamoid position. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency and the metatarsal index were calculated only preoperatively and at last follow-up. Patient satisfaction was assessed using the Visual Analogue Score (VAS). Statistical analysis was carried out using the paired t-test. Statistical significance was set at p < 0.05.
Sponsor: University of Padua

Current Primary Outcome: clinical changes after surgical treatment [ Time Frame: preoperative and at 3-12-48 months post-operative ]

evaluation scale: AOFAS score


Original Primary Outcome: Same as current

Current Secondary Outcome: radiological changes after surgical treatment [ Time Frame: preoperative and at 3-12-48 months post-operative ]

evaluation of the Intermetatarsal angle(IMA) of the first ray, distal metatarsal articular angle of the first metatarsal (DMAA), hallux valgus angle (HVA) and tibial sesamoid position


Original Secondary Outcome: Same as current

Information By: University of Padua

Dates:
Date Received: August 23, 2016
Date Started: May 2010
Date Completion:
Last Updated: August 26, 2016
Last Verified: August 2016