Early Weight Bearing Tarsometatarsal Fusion Study (NCT03812237) | Clinical Trial Compass
CompletedNot Applicable
Early Weight Bearing Tarsometatarsal Fusion Study
United States131 participantsStarted 2012-01-20
Plain-language summary
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis
Who can participate
Age range18 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:
* Patient has signed the Institutional Review Board approved informed consent form specific to this study prior to enrollment
* Failure of conservative treatment (i.e. non-surgical action, consisting of footwear modification in the form of shoes with wide toe boxes, padded inserts, activity modifications and pain control medications)
* Patients who underwent Lapidus procedure with or without other procedures of the first ray (i.e., muscle-tendon procedures, distal metatarsal osteotomy, Akin procedure)
* Patient older than 18 years of age
* Patient is able to give informed consent
* Patient is independent, ambulatory, and agrees to comply with all postoperative visits
Exclusion Criteria:
* Patient has a pre-existing condition which may cause impairment of healing and bone fusion
* Any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study
* Patients who underwent Lapidus arthrodesis in conjunction with other procedures that did not focus on the first pedal ray with the exception of harvesting autogenous ipsilateral calcaneal bone graft