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

NCT04473196 | Recruiting

• 1 other identifier: PTC 2020-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hallux Valgus; Hallux Rigidus

Keywords

MTP Hallux rigidus Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Foot and Ankle Ability Measure (FAAM)

  Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function

  pre op

• Foot and Ankle Ability Measure (FAAM)

  Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function

  6 months

• Visual analogue scale(VAS)

  patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain

  pre op

• Visual analogue scale(VAS)

  patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain

  12 weeks

Secondary Outcomes (1)

• Radiographic healing

  6 weeks

Study Arms (2)

Weightbearing

ACTIVE COMPARATOR

Immediate weightbearing after surgery

Other: weightbearing

Non weightbearing

ACTIVE COMPARATOR

nonweightbearing x 6 weeks post surgery

Other: weightbearing

Interventions

weightbearing OTHER

immediate weightbearing

Also known as: nonweightbearing

Non weightbearing; Weightbearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3h1V7, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 26320560 BACKGROUND

• 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.

  PMID: 24878413 BACKGROUND

• 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.

  PMID: 24685193 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus; Hallux Rigidus

Interventions

Weight-Bearing

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Joint Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Mark Glazebrook, MD FRCS

  NSHA\ Dalhousie UNiversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Francis, RN

CONTACT

9022250199; francisp@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 16, 2020
• Study Start: September 30, 2020
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)