Early Weight Bearing Tarsometatarsal Fusion Study

Orthopaedic Associates of Michigan, PC131 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Hallux Valgus

Interventions

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

Patient were permitted to progressively weightbear on their heel at 2 week post-op.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

TMT Fusion Rate

To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.

Time frame: 6 months

Secondary Outcomes

American Foot & Ankle Society Midfoot Scores (AOFAS)

Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.\] AOFAS Scale: \[0 (no function/severe deformity) to 83 (full function/no limitations/deformity)\]

Time frame: 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 \[1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)\]

Time frame: 12 months

Visual Analogue Scale (VAS)

Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: \[0 (no pain) - 10 (worse possible pain)\]

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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