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The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion

Primary Purpose

Hallux Valgus, Hallux Rigidus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
weightbearing
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hallux Valgus focused on measuring MTP Hallux rigidus Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or great
  • Medically fit for surgery
  • Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs
  • Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification)
  • Surgery is for an isolated 1st MTP fusion
  • Able and willing to comply with follow up schedule and requirements
  • Capable of providing informed consent

Exclusion Criteria:

  • Age <18 years old
  • Surgical booking is for more than just 1st MTP fusion
  • Unable to comply with follow up schedule and requirements
  • Unable to provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Weightbearing

    Non weightbearing

    Arm Description

    Immediate weightbearing after surgery

    nonweightbearing x 6 weeks post surgery

    Outcomes

    Primary Outcome Measures

    Foot and Ankle Ability Measure (FAAM)
    Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
    Foot and Ankle Ability Measure (FAAM)
    Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
    Visual analogue scale(VAS)
    patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
    Visual analogue scale(VAS)
    patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain

    Secondary Outcome Measures

    Radiographic healing
    Union is defined as new bone formation across the cortex of the fusion site

    Full Information

    First Posted
    July 7, 2020
    Last Updated
    July 14, 2020
    Sponsor
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04473196
    Brief Title
    The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
    Official Title
    Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 30, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
    Detailed Description
    The objective of this prospective, randomized controlled trial is to determine if there are any adverse outcomes associated with immediate weight bearing as compared to non-weight bearing following first MTP joint fusion. The primary outcome measures will look at patient reported outcomes of pain and function. The secondary outcome measures will be the difference in the incidence of non-union, as well as adverse events/complications (malunion, wound complications, hardware complications, infection, stress fracture).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus, Hallux Rigidus
    Keywords
    MTP Hallux rigidus Osteoarthritis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Weightbearing
    Arm Type
    Active Comparator
    Arm Description
    Immediate weightbearing after surgery
    Arm Title
    Non weightbearing
    Arm Type
    Active Comparator
    Arm Description
    nonweightbearing x 6 weeks post surgery
    Intervention Type
    Other
    Intervention Name(s)
    weightbearing
    Other Intervention Name(s)
    nonweightbearing
    Intervention Description
    immediate weightbearing
    Primary Outcome Measure Information:
    Title
    Foot and Ankle Ability Measure (FAAM)
    Description
    Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
    Time Frame
    pre op
    Title
    Foot and Ankle Ability Measure (FAAM)
    Description
    Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
    Time Frame
    6 months
    Title
    Visual analogue scale(VAS)
    Description
    patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
    Time Frame
    pre op
    Title
    Visual analogue scale(VAS)
    Description
    patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Radiographic healing
    Description
    Union is defined as new bone formation across the cortex of the fusion site
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or great Medically fit for surgery Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification) Surgery is for an isolated 1st MTP fusion Able and willing to comply with follow up schedule and requirements Capable of providing informed consent Exclusion Criteria: Age <18 years old Surgical booking is for more than just 1st MTP fusion Unable to comply with follow up schedule and requirements Unable to provide informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Francis, RN
    Phone
    9022250199
    Email
    francisp@nshealth.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Glazebrook, MD FRCS
    Organizational Affiliation
    NSHA\ Dalhousie UNiversity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26320560
    Citation
    Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10.
    Results Reference
    background
    PubMed Identifier
    24878413
    Citation
    Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21.
    Results Reference
    background
    PubMed Identifier
    24685193
    Citation
    Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26.
    Results Reference
    background

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    The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion

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