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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2026-08-31

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

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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).

Conditions

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Hallux Valgus Hallux Rigidus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Weightbearing

Immediate weightbearing after surgery

Group Type ACTIVE_COMPARATOR

weightbearing

Intervention Type OTHER

immediate weightbearing

Non weightbearing

nonweightbearing x 6 weeks post surgery

Group Type ACTIVE_COMPARATOR

weightbearing

Intervention Type OTHER

immediate weightbearing

Interventions

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weightbearing

immediate weightbearing

Intervention Type OTHER

Other Intervention Names

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nonweightbearing

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No