Early Weight Bearing Tarsometatarsal Fusion Study

Completed · Not applicable

Conditions studied: Hallux Valgus

In brief

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

Key facts

Study ID

NCT03812237

Run by

Orthopaedic Associates of Michigan, PC

People needed

131

Starts

2012-01-20

Expected to finish

2017-12-01

Last updated by the study team

2019-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orthopaedic Associates of Michigan, PC — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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