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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04473196
• Other study ID #: PTC 2020-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2020
• Source: Nova Scotia Health Authority
• Contact: Patricia Francis, RN
• Phone: 9022250199
• Email: francisp[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus
• Hallux Valgus

Intervention

Other:
• weightbearing
immediate weightbearing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

References & Publications (3)

Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26. Review. — View Citation

Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10. Review. — View Citation

Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot and Ankle Ability Measure (FAAM)	Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function	pre op
Primary	Foot and Ankle Ability Measure (FAAM)	Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function	6 months
Primary	Visual analogue scale(VAS)	patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain	pre op
Primary	Visual analogue scale(VAS)	patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain	12 weeks
Secondary	Radiographic healing	Union is defined as new bone formation across the cortex of the fusion site	6 weeks