Clinical trial NCT04891549: Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures
Official title: TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patella Fracture
Surgery
Orthopedic Disorder
Keywords: patella fracture
surgery
Tension band
Plate
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Randers Regional Hospital
name: Regional Hospital Hjoerring
name: Regional Hospital Kolding
name: Viborg Regional Hospital
First posted: 2021-05-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score - (KOOS5)
timeFrame: One year following treatment
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score - (KOOS5)
timeFrame: 3- and 6 months
measure: Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL.
timeFrame: 3-, 6- and 12-months
measure: EQ-5D-5L questionnaire (5-level version)
timeFrame: 3-, 6- and 12-months
measure: Pain intensity measured on a 10 cm VAS scale
timeFrame: 3-, 6- and 12-months
measure: "PainDETECT" questionnaire
timeFrame: 3-, 6- and 12-months
measure: Bone union
timeFrame: 3-, 6- and 12-months
measure: Maximum isometric knee-extension strength
timeFrame: 12-months
measure: Maximum isometric knee-flexion strength
timeFrame: 12-months
measure: Knee range of motion
timeFrame: 3-, 6- and 12-months
measure: Time to return to work
timeFrame: 3-, 6- and 12-months
Other outcomes:
measure: Harms
timeFrame: 3-, 6- and 12-months
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hjørring
country: Denmark
facility: Regional Hospital Hjoerring
city: Kolding
country: Denmark
facility: Regional Hospital Kolding
city: Randers
country: Denmark
facility: Regional Hospital Randers
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Rasmus Elsoe, MD, PhD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital, Denmark
name: Peter Larsen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: