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Early Weight Bearing Tarsometatarsal Fusion Study | Clinical Trials | Clareo Health

COMPLETEDNA

Early Weight Bearing Tarsometatarsal Fusion Study

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

NCT03812237•Orthopaedic Associates of Michigan, PC

View on ClinicalTrials.gov

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 heel (in a boot) and compare it to standard of care non weight bearing post operative management.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, United States

Key Dates

Start Date

January 20, 2012

Primary Completion Date

July 1, 2017

Completion Date

December 1, 2017

Last Updated

January 31, 2019

Enrollment

131

ACTUAL participants

Conditions

Hallux Valgus

Interventions

(EWB) Early Weight Bearing (2 Weeks Post-op)

OTHER

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RECRUITINGNA

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Hallux ValgusOrthopedic Disorder

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Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Weight Bearing Tarsometatarsal Fusion Study

Inclusion Criteria

Exclusion Criteria

Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery

A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device

Immediate Effect of Taping on Foot Biomechanics in Patients With Hallux Valgus