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

NCT ID: NCT04365712

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-24
• Study Completion Date: 2018-04-27

Brief 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.

Conditions

Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oscillating saw

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

Group Type: ACTIVE_COMPARATOR

Oscillating Saw

Intervention Type: DEVICE

Piezoelectric tool

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

Group Type: EXPERIMENTAL

Piezoelectric tool

Intervention Type: DEVICE

Interventions

Piezoelectric tool

Intervention Type: DEVICE

Oscillating Saw

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Other Identifiers

0035857

Identifier Type: -

Identifier Source: org_study_id