Assessing outcomes and complications in surgical treatment of ankle fractures
Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures: an Observational Study
This study looks at how well surgery works for ankle fractures and what problems might come up afterward by reviewing patient records and feedback from those who had the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 107 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06599554 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the outcomes and complications associated with surgical interventions for distal fibular fractures. It will retrieve and review medical records of patients treated at the IRCCS Rizzoli Orthopedic Institute from January 2019 to January 2024. The study will focus on the effectiveness of anatomical fibula plates and any additional procedures, evaluating pre- and post-operative data, including radiological reports to assess fracture consolidation. Patient questionnaires will also be utilized to gather follow-up scores.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-90 who have undergone surgical treatment for fibula fractures and provided informed consent.
Not a fit: Patients with severe postural instability or neurological conditions that impair mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical techniques and post-operative care for patients with ankle fractures.
How similar studies have performed: Similar studies have shown success in evaluating surgical outcomes for orthopedic procedures, suggesting this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate; * patients of both sexes aged between 18-90 years; * patients who have given their written informed consent to participate in the study Patients in possession of a post-operative control x-ray examination to evaluate consolidation and alignment (x-ray performed as per common clinical practice). Exclusion Criteria: * patients with severe postural instability; * Patients incapable of understanding or wanting; * patients with concomitant neurological pathologies that prevent walking and standing * bedridden patients. * Lack of written informed consent to participate in the study * written form to participate in the study * Physiotherapy not performed
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Zaffagnini, MD
- Email: stefani.zaffagnini@ior.it
- Phone: 0516366
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.