Skip to main content
OpenTrials
Completed

NCT Number: NCT03812237

Early Weight Bearing Tarsometatarsal Fusion Study

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Other names: EWB

Primary outcomes

  1. 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

  1. American Foot & Ankle Society Midfoot Scores (AOFAS)

    Time frame: 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)]

  2. Short Musculoskeletal Function Assessment (SMFA)

    Time frame: 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)]

  3. Visual Analogue Scale (VAS)

    Time frame: 12 months

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

  4. Foot Function Index Revised (FFIr)

    Time frame: 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.

  5. Short Form Health Survey (SF-36) v.2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orthopaedic Associates of Michigan, PC

Other

Collaborators

  • Grand Rapids Medical Education Partners

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.