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

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

Detailed Description
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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).

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

Conditions
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Hallux Valgus, Hallux Rigidus

Intervention / Treatment
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* Other: weightbearing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weightbearing<br>Immediate weightbearing after surgery | Other: weightbearing<br>* immediate weightbearing<br>* Other names: nonweightbearing;|
| Active Comparator: Non weightbearing<br>nonweightbearing x 6 weeks post surgery | Other: weightbearing<br>* immediate weightbearing<br>* Other names: nonweightbearing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Ability Measure (FAAM) | Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function | pre op | 
| Foot and Ankle Ability Measure (FAAM) | Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function | 6 months | 
| Visual analogue scale(VAS) | patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain | pre op | 
| Visual analogue scale(VAS) | patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic healing | Union is defined as new bone formation across the cortex of the fusion site | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTP Hallux rigidus Osteoarthritis