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

Not Applicable

Recruiting

• Conditions: Hallux Valgus; Hallux Rigidus
• Interventions: Other: weightbearing

• Registration Number: NCT04473196
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Study Start: 2020-09-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weightbearing	weightbearing	Immediate weightbearing after surgery
Non weightbearing	weightbearing	nonweightbearing x 6 weeks post surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Radiographic healing	6 weeks	Union is defined as new bone formation across the cortex of the fusion site

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada