The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: weightbearing.
- Who it may be relevant to
- Registry conditions: Hallux Valgus, Hallux Rigidus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Overview
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
Detailed 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).
Interventions
- Other weightbearing
immediate weightbearing
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Radiographic healing [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- Nova Scotia Health Authority — Halifax
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT04473196 · PTC 2020-01