Weil osteotomy alone versus Weil plus plantar plate repair for floating toe
Plantar Plate Repair for Treatment of Floating Toe: Must we Associate it to Weil Osteotomy?
This project will test whether Weil osteotomy alone works as well as Weil osteotomy combined with plantar plate repair for adults with grade II or III floating toe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05625282 on ClinicalTrials.gov |
What this trial studies
This is a prospective non-inferiority comparison of two surgical approaches for adults with grade II or III floating toe. Participants will receive either isolated Weil osteotomy or Weil osteotomy combined with plantar plate repair, with plantar plate injury graded during surgery. Key outcomes include pain, toe function, alignment, and complication or reoperation rates over postoperative follow-up. The protocol excludes patients with plantar plate grades 0, I, or IV and those undergoing secondary surgery.
Who should consider this trial
Good fit: Adults (18 years or older) with symptomatic grade II or III floating toe who can understand treatment and recovery and are eligible for primary surgical correction.
Not a fit: Patients with intraoperative plantar plate grades 0, I, or IV, those requiring secondary surgery, or those unable to follow postoperative care are unlikely to benefit from the procedures tested here.
Why it matters
Potential benefit: If successful, patients might avoid the added surgical complexity and recovery of plantar plate repair while achieving similar pain relief and toe alignment.
How similar studies have performed: Both Weil osteotomy and plantar plate repair are established procedures for forefoot deformities, but direct non-inferiority comparisons for floating toe are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old, minimum * ability to understand treatment and recovery * floating toe Exclusion Criteria: * age less than 18 years old at the moment of recruiting * patients who are not able to understand treatment and recovery * intraoperative diagnosis of plantar plate injury grade 0, I or IV in Nery's classification * secondary surgery
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.