An interventional study of Piezoelectric tool and Oscillating Saw in Hallux Valgus, sponsored by Istituto Ortopedico Rizzoli. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's enrollment of 34 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by common oscillating saw
Device: Oscillating Saw
Patients treated for hallux valgus with 1st metatarsal osteotomy obtained by piezoelectric tool
Device: Piezoelectric tool
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.
Time frame: Preoperative, 21-35-50-70-90-180-360 days of follow up from the surgery
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.
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.
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.
Time frame: Preoperative, 90-180-360 days of follow up from the surgery
No study locations are listed for this record.
Ran from Oct 2014 to primary completion in Apr 2017, 30 months.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 30 months is above that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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