NCT04891549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

May 13, 2021

Last Update Submit

January 14, 2026

Conditions

Patella FractureSurgeryOrthopedic Disorder

Keywords

patella fracturesurgeryTension bandPlate

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score - (KOOS5)

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS 5 subscales.

    One year following treatment

Secondary Outcomes (10)

  • Knee Injury and Osteoarthritis Outcome Score - (KOOS5)

    3- and 6 months

  • Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL.

    3-, 6- and 12-months

  • EQ-5D-5L questionnaire (5-level version)

    3-, 6- and 12-months

  • Pain intensity measured on a 10 cm VAS scale

    3-, 6- and 12-months

  • "PainDETECT" questionnaire

    3-, 6- and 12-months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Harms

    3-, 6- and 12-months

Study Arms (2)

Tension band fixation

ACTIVE COMPARATOR

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

Procedure: Tension band fixation

Plate fixation

EXPERIMENTAL

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.

Procedure: Plate fixation

Interventions

Tension band fixationPROCEDURE

Fracture fixation of the patella fracture with tension band.

Tension band fixation
Plate fixationPROCEDURE

Fracture fixation of the patella fracture with a plate.

Plate fixation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years of age
  • Patella fracture suitable for surgically treatment, with both surgical methods
  • AO classification 34-B, 34-C

You may not qualify if:

  • 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.
  • Prior ipsilateral patella fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Regional Hospital Hjoerring

Hjørring, 9800, Denmark

Location

Regional Hospital Kolding

Kolding, 6000, Denmark

Location

Regional Hospital Randers

Randers, 8930, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

Related Publications (1)

  • Elsoe R, Thorninger R, Severinsen R, Beuke JC, Serritslev R, Jensen SS, Rasmussen MK, Szephalmi P, Petruskevicius J, Barckman J, Bruun NH, Larsen P. Tension band versus locking plate fixation for patella fractures - a protocol of a randomised controlled trial. Dan Med J. 2024 Apr 10;71(5):A12230753. doi: 10.61409/A12230753.

    PMID: 38704836DERIVED

Related Links

MeSH Terms

Conditions

Patella FractureMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Rasmus Elsoe, MD, PhD

    Aalborg University Hospital, Denmark

    STUDY CHAIR

  • Peter Larsen, PT, PhD

    Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Due to the surgical nature of the study the surgeon can not be blinded. The outcome assessor, patients and care providers will be blinded with regards to the two treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of orthopaedic trauma surgery

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

September 1, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.

Locations

DK(6)