Effect of weight bearing on outcomes after first toe joint fusion
Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
This study tests whether allowing people to put weight on their foot right after toe joint surgery can help them feel less pain and recover better compared to not putting weight on it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT04473196 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the impact of immediate weight bearing versus non-weight bearing on patient outcomes following first metatarsophalangeal (MTP) joint fusion. The study will assess primary outcomes related to pain and function reported by patients, as well as secondary outcomes including the incidence of non-union and various complications such as malunion and infection. Participants will be monitored for adverse events to determine the safety and efficacy of early weight bearing post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are medically fit for surgery and have been diagnosed with conditions warranting a first MTP joint fusion.
Not a fit: Patients under 18 years old or those requiring multiple joint fusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery protocols and outcomes for patients undergoing first MTP joint fusion.
How similar studies have performed: While there have been studies on weight bearing in orthopedic surgeries, this specific approach to first MTP joint fusion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Mark Glazebrook, MD FRCS — NSHA\ Dalhousie UNiversity
- Study coordinator: Patricia Francis, RN
- Email: francisp@nshealth.ca
- Phone: 9022250199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.