Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D) (NCT05082012) | Clinical Trial Compass
TerminatedNot Applicable
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Stopped: Corporate decision to early term study to prepare for publication and addition of new studies
United States123 participantsStarted 2021-09-17
Plain-language summary
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Who can participate
Age range14 Years – 58 Years
SexALL
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
âś“. Male and females between the ages 14 and 58 years at the time of consent;
âś“. Closed physeal plates at the time of consent;
âś“. Intermetatarsal angle is between 10.0Ëš - 22.0Ëš;
âś“. Hallux valgus angle is between 16.0Ëš - 40.0Ëš;
âś“. Willing and able to adhere to early weight-bearing instructions post-operatively;
âś“. Capable of completing self-administered questionnaires;
âś“. Acceptable surgical candidate, including use of general anesthesia;
âś“. Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure;
Exclusion criteria
âś•. Previous surgery for hallux valgus on operative side;
âś•. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits);