Clinical trial NCT03812237: Early Weight Bearing Tarsometatarsal Fusion Study
Official title: A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Lapidus Arthrodesis
Early Weight Bearing
First Tarsometatarsal Arthrodesis
Lead sponsor: Orthopaedic Associates of Michigan, PC
Sponsor class: OTHER
Collaborators: name: Grand Rapids Medical Education Partners
First posted: 2019-01-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled Trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: TMT Fusion Rate
timeFrame: 6 months
Secondary outcomes:
measure: American Foot & Ankle Society Midfoot Scores (AOFAS)
timeFrame: 12 months
measure: Short Musculoskeletal Function Assessment (SMFA)
timeFrame: 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: 12 months
measure: Foot Function Index Revised (FFIr)
timeFrame: 12 months
measure: Short Form Health Survey (SF-36) v.2
timeFrame: 12 months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, PC
state: Michigan
Study officials:
References:
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