Hallux ValgusPiezo-HalluxNCT04365712
Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel
A study testing Piezoelectric tool and Oscillating Saw in people with Hallux Valgus, run by Istituto Ortopedico Rizzoli.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Piezoelectric tool and Oscillating Saw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2014to 27 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Piezoelectric tool, Oscillating Saw
- Keywords
- Hallux valgus, Radiographic consolidation, Piezoelectric scalpel
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric toolDevice
Oscillating SawDevice
| Study group | Role | What they receive |
|---|---|---|
| Oscillating saw | Active comparator | Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by common oscillating saw Receives: Device: Oscillating Saw |
| Piezoelectric tool | Experimental | Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by piezoelectric tool Receives: Device: Piezoelectric tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Preoperative, 90-180-360 days of follow up from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start24 Oct 2014
- Primary completion27 Apr 2017
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Russo, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365712
- Sponsor's protocol ID
- 0035857
- Acronym
- Piezo-Hallux
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezoelectric Tools Versus Traditional Oscillating Saw for Distal Linear Osteotomy in Hallux Valgus Correction: a Prospective, Triple-blinded, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04365712
- Acronym / sponsor ID
- Piezo-Hallux / 0035857
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, Radiographic consolidation, Piezoelectric scalpel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oscillating saw | Active comparator | Device: Oscillating SawPatients treated for hallux valgus with 1st metatarsal osteotomy obtained by common oscillating saw |
| Piezoelectric tool | Experimental | Device: Piezoelectric toolPatients treated for hallux valgus with 1st metatarsal osteotomy obtained by piezoelectric tool |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezoelectric tool | Device | Piezoelectric tool |
| Oscillating Saw | Device | Oscillating saw |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Russo, MD principal investigator
Istituto Ortopedico Rizzoli
Questions about this trial
What is this clinical trial studying?
A study testing Piezoelectric tool and Oscillating Saw in people with Hallux Valgus, run by Istituto Ortopedico Rizzoli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Preoperative, 21-35-50-70-90-180-360 days of follow up from the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.