randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
92
immediate weightbearing
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
RECRUITINGFoot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function
Time frame: pre op
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function
Time frame: 6 months
Visual analogue scale(VAS)
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Time frame: pre op
Visual analogue scale(VAS)
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
Time frame: 12 weeks
Radiographic healing
Union is defined as new bone formation across the cortex of the fusion site
Time frame: 6 weeks
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