Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

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

Exclusion Criteria

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

Summary

Conditions
  • Hallux Rigidus
  • Hallux Valgus
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 an...

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).

Inclusion Criteria

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT04473196
Collaborators
Not Provided
Investigators
  • Principal Investigator: Mark Glazebrook, MD FRCS NSHA\ Dalhousie UNiversity
  • Mark Glazebrook, MD FRCS NSHA\ Dalhousie UNiversity