CompletedNot Applicable

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

34 participantsStarted 2014-10-24

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT04365712

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-27

View on ClinicalTrials.gov More Hallux Valgus trials