A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 131
- Locations
- 2
- Primary Endpoint
- TMT Fusion Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Patients were blinded to treatment until their 2 week post-operative visit.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
(EWB) Early Weight Bearing (2 Weeks Post-op)
Subjects in the EWB group were allowed to begin bearing 50 pounds (lbs) through their hindfoot in either the boot or the short leg cast at the two-week visit. They were allowed to advance their weightbearing as tolerated by 25 lbs every four days until full weightbearing through the hindfoot was achieved.
Intervention: (EWB) Early Weight Bearing (2 Weeks Post-op) (Other)
(SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)
Subjects in the SOC group were allowed to heel touch weightbear for balance only on the operative foot until the six to eight week visit. At this visit all subjects were placed into a short leg walking boot. Non-weightbearing patients were permitted to begin the progressive weightbearing protocol, without hindfoot restriction.
Outcomes
Primary Outcomes
TMT Fusion Rate
Time Frame: 6 months
To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.
Secondary Outcomes
- Visual Analogue Scale (VAS)(12 months)
- Foot Function Index Revised (FFIr)(12 months)
- Short Form Health Survey (SF-36) v.2(12 months)
- American Foot & Ankle Society Midfoot Scores (AOFAS)(12 months)
- Short Musculoskeletal Function Assessment (SMFA)(12 months)
Investigators
John G. Anderson, MD
Orthopaedic Surgeon - Foot and Ankle
Orthopaedic Associates of Michigan, PC