Status:
COMPLETED
Early Weight Bearing Tarsometatarsal Fusion Study
Lead Sponsor:
Orthopaedic Associates of Michigan, PC
Collaborating Sponsors:
Grand Rapids Medical Education Partners
Conditions:
Hallux Valgus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT03812237
Start Date
January 20 2012
End Date
December 1 2017
Last Update
January 31 2019
Active Locations (1)
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1
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States, 49525