Early Weight Bearing Tarsometatarsal Fusion Study

Study Overview
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Brief Summary
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A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis

Detailed Description
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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.

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

Conditions
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Hallux Valgus

Intervention / Treatment
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* Other: (EWB) Early Weight Bearing (2 Weeks Post-op)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (EWB) Early Weight Bearing (2 Weeks Post-op)<br>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. | Other: (EWB) Early Weight Bearing (2 Weeks Post-op)<br>* Patient were permitted to progressively weightbear on their heel at 2 week post-op.<br>* Other names: EWB;|
| No Intervention: (SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMT Fusion Rate | To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Foot & Ankle Society Midfoot Scores (AOFAS) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.] AOFAS Scale: [0 (no function/severe deformity) to 83 (full function/no limitations/deformity)] | 12 months | 
| Short Musculoskeletal Function Assessment (SMFA) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 [1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)] | 12 months | 
| Visual Analogue Scale (VAS) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)] | 12 months | 
| Foot Function Index Revised (FFIr) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. FFIr Scale: 67 items scored 1 to 7 [1(no problems/no difficulty/not bothered) - 6 (unable to do a task/symptoms all the time/worst pain imaginable) - 7 (Not applicable)]. Score range: 46 to 230. | 12 months | 
| Short Form Health Survey (SF-36) v.2 | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SF-36 v.2 Scale: Self-reporting outcomes assessment [0 (no function/severe physical/mental disability) to 100 (full function, no limitations to mental/physical health)]. Score range: 46 to 230. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lapidus Arthrodesis, Early Weight Bearing, First Tarsometatarsal Arthrodesis