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

N

Nova Scotia Health Authority (NSHA)

Status

Unknown

Conditions

Hallux Rigidus
Hallux Valgus

Treatments

Other: weightbearing

Study type

Interventional

Funder types

Other

Identifiers

NCT04473196
PTC 2020-01

Details and patient eligibility

About

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

Full 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).

Enrollment

92 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

92 participants in 2 patient groups

Weightbearing
Active Comparator group
Description:
Immediate weightbearing after surgery
Treatment:
Other: weightbearing
Non weightbearing
Active Comparator group
Description:
nonweightbearing x 6 weeks post surgery
Treatment:
Other: weightbearing

Trial contacts and locations

0

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Central trial contact

Patricia Francis, RN

Data sourced from clinicaltrials.gov

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