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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04473196

Enrollment

Registered

2020-07-16

Start date

2020-09-30

Completion date

2026-08-31

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Rigidus, Hallux Valgus

Keywords

MTP Hallux rigidus Osteoarthritis

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).

Interventions

OTHERweightbearing

immediate weightbearing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Contacts

Primary ContactPatricia Francis, RN

francisp@nshealth.ca9022250199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026