Early Weight Bearing Tarsometatarsal Fusion Study

Not Applicable

Completed

• Conditions: Hallux Valgus

• Registration Number: NCT03812237
• Lead Sponsor: Orthopaedic Associates of Michigan, PC

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 Timeline

• Study Start: 2012-01-20
• Primary Completion: 2017-07-01
• Study Completion: 2017-12-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-23
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TMT Fusion Rate	6 months	To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	12 months	Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: \[0 (no pain) - 10 (worse possible pain)\]
Foot Function Index Revised (FFIr)	12 months	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.
Short Form Health Survey (SF-36) v.2	12 months	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.
American Foot & Ankle Society Midfoot Scores (AOFAS)	12 months	Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.\] AOFAS Scale: \[0 (no function/severe deformity) to 83 (full function/no limitations/deformity)\]
Short Musculoskeletal Function Assessment (SMFA)	12 months	Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 \[1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)\]

Trial Locations

Locations (1)

Orthopaedic Associates of Michigan, PC; 🇺🇸 Grand Rapids, Michigan, United States