Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT04473196

Conditions

Hallux Valgus

Hallux Rigidus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

weightbearing

Study Details

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

Study ID

NCT04473196

Start date

Sep 30, 2020

Status verified date

Aug, 2024

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Weightbearing

Immediate weightbearing after surgery

active comparator: Non weightbearing

nonweightbearing x 6 weeks post surgery

Interventions

weightbearing

immediate weightbearing

Primary outcome measure

  • Foot and Ankle Ability Measure (FAAM) [ Time Frame: pre op ]
  • Foot and Ankle Ability Measure (FAAM) [ Time Frame: 6 months ]
  • Visual analogue scale(VAS) [ Time Frame: pre op ]
  • Visual analogue scale(VAS) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Patricia Francis, RN

9022250199francisp@nshealth.ca

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3h1V7

Contacts

Trish Francis

trish.francis@nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 23, 2024

Last verified

Aug, 2024

Keywords

  • MTP Hallux rigidus Osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-23.