Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
| Registry | NCT04473196 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 92 (Estimated) |
| Sponsor | Nova Scotia Health Authority (Other) |
| Conditions | Hallux Valgus, Hallux Rigidus |
| Interventions | weightbearing (Other) |
| Dates | start 2020-09-30, primary completion 2025-08-31 (estimated), completion 2026-08-31 (estimated), first posted 2020-07-16, last updated 2024-08-23 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Hallux Valgus All trials for Hallux Rigidus All trials of weightbearing
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Weightbearing | Active comparator | Other: weightbearing | Immediate weightbearing after surgery |
| Non weightbearing | Active comparator | Other: weightbearing | nonweightbearing x 6 weeks post surgery |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Nova Scotia Health Authority | Halifax, Nova Scotia | Canada | Recruiting |