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

May 11, 2023 updated by: Istituto Ortopedico Rizzoli

Piezoelectric Tools Versus Traditional Oscillating Saw for Distal Linear Osteotomy in Hallux Valgus Correction: a Prospective, Triple-blinded, Randomized Controlled Study.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oscillating saw
Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by common oscillating saw
Experimental: Piezoelectric tool
Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by piezoelectric tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
23/5000 Radiographic healing. Patients underwent several radiographic checks, pre-operatively and follow-ups, in order to analyze the healing changes in the osteotomy of 1 metatarsus
Time Frame: Preoperative, 21-35-50-70-90-180-360 days of follow up from the surgery
The patients underwent radiographic control (foot in two projections under load) preoperatively and at 21-35-50-70-90-180-360 days of follow up from the surgery. The radiographs obtained were evaluated by an independent radiologist, always the same for the duration of the study, who was not aware of the type of instrument used during the surgery. His task was to evaluate at what time of follow-up the radiographic consolidation of the osteotomy was achieved.
Preoperative, 21-35-50-70-90-180-360 days of follow up from the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAs metatarsophalangeal (MTP)-interphalangeal (IP)- American Orthopaedic Foot & Ankle score. The questionnaire was administered pre-operatively and to some follow-ups in order to evaluate the changes in the patient's clinic.
Time Frame: Preoperative, 90-180-360 days of follow up from the surgery

Patients completed a clinical evaluation questionnaire (AOFAs metatarsophalangeal (MTP)-interphalangeal (IP)- American Orthopaedic Foot & Ankle score). It is a clinical test commonly used in the scientific literature, which serves to evaluate, in terms of value from 0 to 100, the autonomy, pain, stability, and alignment of the hallux of the patient.

The questionnaire was collected preoperatively and at 90-180-360 days of follow-up from surgery. No follow-up questionnaires were submitted before 90 days to avoid the influence of post-operative pain.

Preoperative, 90-180-360 days of follow up from the surgery
VAS - Visual Analogue Scale. The questionnaire was administered pre-operatively and to some follow-ups in order to evaluate the changes in the patient's clinic.
Time Frame: Preoperative, 90-180-360 days of follow up from the surgery

Patients completed a clinical evaluation questionnaire (VAS - Visual Analogue Scale). It is a measurement instrument that tries to measure a characteristic or attitude, for example, the amount of pain that a patient feels ranges across a continuum from none (0) to an extreme amount of pain (10).

The VAS was collected preoperatively and at 90-180-360 days of follow-up from surgery. No follow-up questionnaires were submitted before 90 days to avoid the influence of post-operative pain.

Preoperative, 90-180-360 days of follow up from the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alessandro Russo, MD, Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2014

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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