Early Weight Bearing Tarsometatarsal Fusion Study



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:January 20, 2012
End Date:December 1, 2017

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

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
We found this trial at
1
site
Grand Rapids, Michigan 49525
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from
Grand Rapids, MI
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