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

Last updated: August 21, 2024
Sponsor: Nova Scotia Health Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

weightbearing

Clinical Study ID

NCT04473196
PTC 2020-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or great

  • Medically fit for surgery

  • Patients diagnosed with condition for which a 1st MTP joint fusion is a surgicalmanagement option based on clinical examination and radiographs

  • Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wearmodification)

  • 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

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

Study Design

Total Participants: 92
Treatment Group(s): 1
Primary Treatment: weightbearing
Phase:
Study Start date:
September 30, 2020
Estimated Completion Date:
August 31, 2026

Study 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).

Connect with a study center

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3h1V7
    Canada

    Active - Recruiting

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