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

NCT04365712 | Completed

• 1 other identifier: 0035857
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hallux Valgus

Keywords

Hallux valgus; Radiographic consolidation; Piezoelectric scalpel

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• 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.

  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.

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

Study Arms (2)

Oscillating saw

ACTIVE COMPARATOR

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

Device: Oscillating Saw

Piezoelectric tool

EXPERIMENTAL

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

Device: Piezoelectric tool

Interventions

Piezoelectric tool DEVICE

Piezoelectric tool

Oscillating Saw DEVICE

Oscillating saw

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Alessandro Russo, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient did not know with which instrument the osteotomy had been performed. The radiologist who certifies the osteotomy radiographic healing did not know with which instrument the osteotomy had been performed. The clinical investigator who collected the evaluation questionnaires was not aware of the type of instruments used during the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: October 24, 2014
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2018
• Last Updated: May 15, 2023

Record last verified: 2020-04