A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis

The purpose of this prospective randomized control trial is to assess outcomes in patients who undergo modified Lapidus arthrodesis and whose postoperative management includes early weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post operative management.

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

Patients were blinded to treatment until their 2 week post-operative visit.