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

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04473196
Collaborator
(none)
92
Enrollment
2
Arms
35
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions

Condition or Disease Intervention/Treatment Phase
  • Other: weightbearing
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Anticipated Study Start Date :
Sep 30, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Weightbearing

Immediate weightbearing after surgery

Other: weightbearing
immediate weightbearing
Other Names:
  • nonweightbearing

    		•
    Active Comparator: Non weightbearing

    nonweightbearing x 6 weeks post surgery

    Other: weightbearing
    immediate weightbearing
    Other Names:
  • nonweightbearing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Foot and Ankle Ability Measure (FAAM) [pre op]

      Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function

    2. Foot and Ankle Ability Measure (FAAM) [6 months]

      Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function

    3. Visual analogue scale(VAS) [pre op]

      patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain

    4. Visual analogue scale(VAS) [12 weeks]

      patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain

    Secondary Outcome Measures

    1. Radiographic healing [6 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nova Scotia Health Authority

    Investigators

    • Principal Investigator: Mark Glazebrook, MD FRCS, NSHA\ Dalhousie UNiversity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mark Glazebrook, MSc, PhD, Dip Sports Med., MD, F.R.C.S. (C) Professor of Surgery Dalhousie University, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT04473196
    Other Study ID Numbers:
    • PTC 2020-01
    First Posted:
    Jul 16, 2020
    Last Update Posted:
    Jul 16, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mark Glazebrook, MSc, PhD, Dip Sports Med., MD, F.R.C.S. (C) Professor of Surgery Dalhousie University, Nova Scotia Health Authority
    MTP Hallux rigidus Osteoarthritis
    Additional relevant MeSH terms:
    Hallux Valgus
    Hallux Rigidus
    Hallux Limitus

    Study Results

    No Results Posted as of Jul 16, 2020