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NCT Number: NCT04473196

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

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

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Key information

Conditions

Hallux Valgus Foot Deformities Foot Deformities, Acquired Hallux Rigidus Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3h1V7, Canada

Location status: Recruiting

Location contact

Trish Francis

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

weightbearing

Other

immediate weightbearing

Other names: nonweightbearing

Primary outcomes

  1. Foot and Ankle Ability Measure (FAAM)

    Time frame: pre op

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

  2. Foot and Ankle Ability Measure (FAAM)

    Time frame: 6 months

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

  3. Visual analogue scale(VAS)

    Time frame: pre op

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

  4. Visual analogue scale(VAS)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Radiographic healing

    Time frame: 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Francis, RN

CONTACT

[email protected]

9022250199

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2020
Registry last updated
Aug 23, 2024

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.

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