Comparing two surgical methods for treating patella fractures
TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial
This study is testing which surgical method, locking plate fixation or standard tension band fixation, works better for people with patella fractures by looking at how they feel a year after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT04891549 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial aims to compare the effectiveness of locking plate fixation versus standard tension band fixation in patients with patella fractures. The study is designed as a prospective, assessor-blinded, randomized trial, focusing on patient-reported outcomes measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS5) after one year. Secondary analyses will explore various factors such as pain, muscle atrophy, and time to return to work, although these are not the primary objectives of the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a patella fracture suitable for surgical treatment using either fixation method.
Not a fit: Patients with open patella fractures above Gustillo grade 2, bilateral patella fractures, or those who have had a total knee replacement in the affected leg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical method for treating patella fractures, potentially improving patient outcomes.
How similar studies have performed: Other studies comparing surgical fixation methods for fractures have shown varying degrees of success, but this specific comparison of locking plate versus tension band fixation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Above 18 years of age * Patella fracture suitable for surgically treatment, with both surgical methods * AO classification 34-B, 34-C Exclusion Criteria: * Open patella fracture above Gustillo grade 2 * Bilateral patella fracture * Total knee replacement in the affected extremity * Other fractures of the affected extremity within the previous 12 months. * Other reasons for exclusion (unable to understand Danish, mentally unable to participate, etc). * Prior ipsilateral patella fracture
Where this trial is running
Aalborg and 5 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Regional Hospital Hjoerring — Hjørring, Denmark (Recruiting)
- Regional Hospital Kolding — Kolding, Denmark (Recruiting)
- Regional Hospital Randers — Randers, Denmark (Recruiting)
- Regional Hospital Viborg — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Peter Larsen, PT, PhD — Aalborg University Hospital, Denmark
- Study coordinator: Rasmus Elsoe, MD, PhD
- Email: rae@rn.dk
- Phone: +4597660000
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.