Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures (TENPLA)

Rasmus Elsøe

Status: Completed

Conditions: Orthopedic Disorder; Surgery; Patella Fracture

Treatments: Procedure: Plate fixation; Procedure: Tension band fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04891549

LERG2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 2 patient groups

Tension band fixation

Active Comparator group

Description:

Surgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice.

Treatment:

Procedure: Tension band fixation

Plate fixation

Experimental group

Description:

Surgical fixation of the patella fracture utilizing the AO principles and a locking plate with the number of screws by surgeons choice. Additional fixation by surgeons choice.

Treatment:

Procedure: Plate fixation