Comparing hardware retention versus removal for Lisfranc injuries
A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
NA · University of Calgary · NCT02374944
This study is testing whether keeping or removing surgical hardware after fixing Lisfranc injuries helps patients recover better and feel more functional over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 3 sites (Calgary, Alberta and 2 other locations) |
| Trial ID | NCT02374944 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective randomized control trial aims to compare the outcomes of hardware retention versus hardware removal in patients who have undergone surgical fixation for Lisfranc injuries. Eligible participants will be randomized to either retain their hardware for a minimum of two years or have it removed after six months. The study will assess outcomes at multiple time points, including 6 weeks, 12 weeks, 6 months, 1 year, and 2 years post-enrollment. The goal is to determine which approach leads to better recovery and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals who have sustained a Lisfranc injury and have undergone surgical fixation within 28 days of the injury.
Not a fit: Patients who have not had a Lisfranc injury or those who are not medically fit for anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal management of hardware in Lisfranc injuries, potentially improving patient recovery and outcomes.
How similar studies have performed: While there have been studies on hardware management in orthopedic injuries, this specific comparison of retention versus removal in Lisfranc injuries is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has Lisfranc injury that was treated within 28 days of injury. * Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation. * The patient must be medically fit for anesthesia * Subject is willing and able to provide written informed consent for trial participation * Subject is willing and able to comply with the study protocol including return for all follow-up evaluations * Subject may have a bony, ligamentous, or combined lisfranc injury * Demonstrated instability of the lisfranc complex on static, stress view or CT radiography. * Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon * Adequate reduction to within 1mm of lisfranc complex at time of fixation * Hardware across the midfoot (tarsal-metatarsal joints 1-3) Exclusion Criteria: * Subject has a significant pre-existing foot injury * Subject has a delay in initial treatment greater than 28 days from time of injury * Subject has an active infection in the area of surgical approach requiring surgical debridement * Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury) * Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex * Subject has a high risk of death from surgery (ASA physical status Class V) * Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.) * Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires * Subject is pregnant * There has been loss of fixation or reduction prior to enrollment * Previous corrective foot surgery * Associated fracture of calcaneus, talus, or tibial plafond. * Pathologic fracture * Loss of fixation or reduction prior to enrollment
Where this trial is running
Calgary, Alberta and 2 other locations
- Foothills Medical Centre — Calgary, Alberta, Canada (RECRUITING)
- Peter Lougheed Centre — Calgary, Alberta, Canada (ACTIVE_NOT_RECRUITING)
- South Health Campus — Calgary, Alberta, Canada (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Paul J Duffy, MD — University of Calgary
- Study coordinator: Karin Lienhard, PhD
- Email: karin.lienhard@ucalgary.ca
- Phone: 403-944-2932
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.
Conditions: Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint