Clinical trial NCT04365712: Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel
Official title: Piezoelectric Tools Versus Traditional Oscillating Saw for Distal Linear Osteotomy in Hallux Valgus Correction: a Prospective, Triple-blinded, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Hallux valgus
Radiographic consolidation
Piezoelectric scalpel
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: Preoperative, 21-35-50-70-90-180-360 days of follow up from the surgery
Secondary outcomes:
measure: 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.
timeFrame: Preoperative, 90-180-360 days of follow up from the surgery
measure: 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.
timeFrame: Preoperative, 90-180-360 days of follow up from the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Alessandro Russo, MD
role: PRINCIPAL_INVESTIGATOR
References: