- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04365712
Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel (Piezo-Hallux)
Piezoelectric Tools Versus Traditional Oscillating Saw for Distal Linear Osteotomy in Hallux Valgus Correction: a Prospective, Triple-blinded, Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Alessandro Russo, MD, Istituto Ortopedico Rizzoli
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0035857
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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