Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel (Piezo-Hallux)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Hallux Valgus

Treatments: Device: Oscillating Saw; Device: Piezoelectric tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04365712

0035857

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80
• Mild to moderate hallux valgus (Hallux valgus Angle <; 40° and Intermetatarsal Angle < 20°),
• No osteoarthritis or grade 1 osteoarthritis of the first metatarsophalangeal joint (MTPj) according to Regnauld grading

Exclusion criteria

• Stiffness of the first MTPj or osteoarthritis ≥ grade 2 according to Regnauld's classification
• Rheumatoid arthritis or other chronic inflammatory joint diseases
• Diabetes
• Neurological disorders
• Previous hallux valgus surgical corrections
• Hypermobility of the first MTPj as per congenital laxity syndromes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Oscillating saw

Active Comparator group

Description:

Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by common oscillating saw

Treatment:

Device: Oscillating Saw

Piezoelectric tool

Experimental group

Description:

Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by piezoelectric tool

Treatment:

Device: Piezoelectric tool