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

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

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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