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AzTrials

Patella FractureTENPLANCT04891549

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

A study testing Tension band fixation and Plate fixation in people with Patella Fracture and Surgery, run by Rasmus Elsøe at 6 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patella Fracture, Surgery, Orthopedic Disorder
What is being tested?
Tension band fixation and Plate fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
6 sitesDenmark
Study dates
1 Sep 2021to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Denmark6 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Regional Hospital Hjoerring

    Hjørring, 9800

  • Regional Hospital Kolding

    Kolding, 6000

  • Regional Hospital Randers

    Randers, 8930

  • Regional Hospital Viborg

    Viborg, 8800

Other trials in Denmark

About this study

Official title: TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial

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.

Read the 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.

Being tested
Tension band fixation, Plate fixation
Keywords
patella fracture, surgery, Tension band, Plate
Medical subject headings
Patella Fracture, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tension band fixationProcedure or surgery

    Fracture fixation of the patella fracture with tension band.

  • Plate fixationProcedure or surgery

    Fracture fixation of the patella fracture with a plate.

Study groups in NCT04891549
Study groupRoleWhat they receive
Tension band fixationActive comparatorSurgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice.
Receives: Procedure: Tension band fixation
Plate fixationExperimentalSurgical 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.
Receives: Procedure: Plate fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: One year following treatment

Secondary outcomes (10)

  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 KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

    Measured: 3- and 6 months

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

    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 KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

    Measured: 3-, 6- and 12-months

  3. EQ-5D-5L questionnaire (5-level version)

    General health will be assessed using EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death.

    Measured: 3-, 6- and 12-months

  4. Pain intensity measured on a 10 cm VAS scale

    Development in pain will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.

    Measured: 3-, 6- and 12-months

  5. "PainDETECT" questionnaire

    Knee pain and neuropathic pain will be assessed using the "PainDETECT" questionnaire. The "PainDETECT" screening questionnaire uses a scoring method between 1-38. A total score of 1 indicates no symptoms, and 38 indicates major symptoms.

    Measured: 3-, 6- and 12-months

  6. Bone union

    Bone union, will be evaluated on standard AP and side X-rays of the fractured patella. The evaluation of bone union will be defined as: i) visible callus formation, diminished no visible fracture line and no pain from the fracture site at weight-bearing and at clinical examination.

    Measured: 3-, 6- and 12-months

  7. Maximum isometric knee-extension strength

    Maximum isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK)

    Measured: 12-months

  8. Maximum isometric knee-flexion strength

    Maximum isometric knee-flexion strength at 90 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK)

    Measured: 12-months

  9. Knee range of motion

    Knee range of motion. With the patient supine on an examination table the full range of passive motion in both knee joints will be measured using a standard goniometer.

    Measured: 3-, 6- and 12-months

  10. Time to return to work

    Measure the time from surgery to end of sick leave measured in days

    Measured: 3-, 6- and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04891549
Sponsor's protocol ID
LERG2
Acronym
TENPLA
Status last verified
Jan 2026
First submitted
13 May 2021
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: A detailed statistical analysis plan will be made publicly available before the last patient is included in the study.

Publications

  • 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.

    PubMed 38704836

Questions about this trial

What is this clinical trial studying?

A study testing Tension band fixation and Plate fixation in people with Patella Fracture and Surgery, run by Rasmus Elsøe at 6 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score - (KOOS5) (time frame: One year following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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