Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      The main goal of the surgical correction of the hallux valgus is the morphological correction
      associated with the functional rebalancing of the first ray. The aim of this study was to
      show the efficacy of piezosurgery in performing distal linear osteotomy of the first
      metatarsal bone in hallux valgus correction, in terms of clinical and radiological outcomes
      at 1-year final follow up.
    

Detailed description: 
      This study was performed collecting pre-operative and post-operative data for all patients.

      At the time of admission, the patients received and signed an Informed Consent to adhere to
      the Study Protocol. On this occasion, the patients were also given a summary scheme of the
      clinical and radiographic checks to which they would have undergone in case of adherence to
      the Study Protocol.

      40 patients were included in the trial and were randomly allocated (1:1) in a Piezoelectric
      Group (PG) and in a Control Group (CG) (that provided for the use of a traditional
      oscillating saw) utilizing sealed envelopes. The envelopes were prepared and shuffled by the
      same senior surgeon involved in the surgical procedures and drawn by a researcher not
      involved in the surgical procedures or the clinical and radiographic assessment.

      The patients were not aware of the instrument used during surgery. In both groups, patients
      were treated with the same surgical technique, a distal linear osteotomy of the first
      metatarsal bone (S.E.R.I. technique). Clinical and radiographic assessments were performed
      during the multiple follow-ups.

      The final follow-up was at 1 year.
    

Intervention name(s): Piezoelectric tool; Oscillating Saw
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 patients affected by hallux valgus were recruited, based on the listed inclusion and exclusion criteria; 20 underwent 1st metatarsal osteotomy treated with a piezoelectric tool (experimental group) and 20 underwent 1st metatarsal osteotomy with a traditional oscillating saw (control group). The patients were randomly allocated (1:1) in a Piezoelectric Group (PG) and in a Control Group (CG) utilizing sealed envelopes. The envelopes were prepared and shuffled by the same senior surgeon involved in the surgical procedures and drawn by a researcher not involved in the surgical procedures or the clinical and radiographic assessment.
3 patients in PG (1 did not comply with the post-operative management and 2 missed the scheduled follow-up appointments) and 3 patients in CG (all patients discontinued from the evaluations) were lost to follow-up.
Thus, 17 patients in each group were evaluated in the 1-year analysis, all treated according to their original assignment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hallux valgus; Radiographic consolidation; Piezoelectric scalpel