Overview
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.
Description
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.
Primary objective The overall objective of the study is to compare the 1-year patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS5) after standard tension band fixation with locking plat fixation for patients with patella fractures.
Secondary objectives Several other analyses are of interest and are planned but are not objectives of this study. Therefore, these analyses will, for the major part, hypothesis-generating. Analyses of this type include, but are not limited to harms, muscle atrophy, pain, general health, gait function, time to return to work and economical consequences between the two groups.
Eligibility
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