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NCT06570590
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
NA trial testing Minimally invasive lapidus procedure with no arthroscopy in Hallux Valgus and Bunion in 58 participants. Not yet recruiting.
1 October 2026
Quick facts
| Lead sponsor | St. Paul's Hospital, Canada |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 1 October 2024 |
| Primary completion | 1 October 2026 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Minimally invasive lapidus procedure with no arthroscopy
- Minimally invasive lapidus procedure with arthroscopy
Conditions studied
- Hallux Valgus and Bunion — all drugs for Hallux Valgus and Bunion →
Sponsor
St. Paul's Hospital, Canada
Who can join
19 and older, any sex, with Hallux Valgus and Bunion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a newer approach. Because it's newer, there is not studies on how patients feel about it directly through patient reported outcomes (PROMs), which involve patients filling out questionnaires. Previous studies have looked at information that could be gathered from radiographs. This study looks specifically at how well bones heal after the MIS procedure and how patients feel about it based on their recorded responses in PROMs. The Lapidus procedure involves a step where the surgeon checks for the amount of cartilage removal, which can be done by inserting a mini camera into the joint (arthroscopically) or through a small incision for visual inspection. These two methods of checking cartilage removal are the two treatment groups for this study that patients are randomly assigned to. The main goals of the study are as follows: * To determine healing in minimally invasive Lapidus. Evaluated by bones fusing together at 12 weeks post-operation. * To determine patient reported outcomes following Lapidus procedures * To determine the relationship between patient-reported outcomes and percent bone healing. * To assess the nonunion (bone not fusing together) rate and re-operation rate following Lapidus procedures * To assess the correction achieved on radiographic and standing CT measurements. * To compare radiographic and Standing CT assessment of hallux valgus deformity and correction after surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06570590
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06570590 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Paul's Hospital, Canada
- Last refreshed: 26 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06570590.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing