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Early Weight Bearing Tarsometatarsal Fusion Study

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ClinicalTrials.gov Identifier: NCT03812237
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Grand Rapids Medical Education Partners
Information provided by (Responsible Party):
John G. Anderson, MD, Orthopaedic Associates of Michigan, PC

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

Condition or disease Intervention/treatment Phase
Hallux Valgus Other: (EWB) Early Weight Bearing (2 Weeks Post-op) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled Trial
Masking: None (Open Label)
Masking Description: Patients were blinded to treatment until their 2 week post-operative visit.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis
Actual Study Start Date : January 20, 2012
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: (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.
 Other: (EWB) Early Weight Bearing (2 Weeks Post-op)
Patient were permitted to progressively weightbear on their heel at 2 week post-op.
Other Name: EWB
No Intervention: (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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812237


Locations
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United States, Michigan
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States, 49525
Sponsors and Collaborators
Orthopaedic Associates of Michigan, PC
Grand Rapids Medical Education Partners
More Information
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Publications of Results:

Other Publications:

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Responsible Party: John G. Anderson, MD, Orthopaedic Surgeon - Foot and Ankle, Orthopaedic Associates of Michigan, PC
ClinicalTrials.gov Identifier: NCT03812237    
Other Study ID Numbers: OAM-TMT-01
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John G. Anderson, MD, Orthopaedic Associates of Michigan, PC:
Lapidus Arthrodesis
Early Weight Bearing
First Tarsometatarsal Arthrodesis
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases