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CompletedNCT02015975Updated Jul 26, 2018

Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

An observational study in Fracture of Patella, sponsored by Diakoniekrankenhaus Friederikenstift. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Diakoniekrankenhaus Friederikenstift · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

Depending on the fracture pattern of patellar fractures tension band wiring, interfragmentary screw fixation or combinations are common treatments. But there are several problems associated with these techniques as fracture dislocation or loosening and perforation of the wire. Furthermore an anatomic reduction with stable fixation in comminuted fractures is almost impossible to achieve.

A new option in the treatment of patellar fractures is the locking plate osteosynthesis, which provides a more stable fixation and higher mechanical strength in biomechanical tests compared to classic tension band wiring. Due to various screw positioning a stable fixation in comminuted fractures can be achieved and an early functional treatment with full weight bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems not to be essential anymore and the blood supply is not to be compromised.

Because of the absent of clinical evidence investigators want to evaluate the clinical outcome after locking plate osteosyntheses in patellar fractures and compare patient satisfaction, functional motion, complications and number of revisions with common treatments.

02

Conditions studied

  • Fracture of Patella

Keywords

  • patellar fracture
  • fracture of patella
  • patella
  • locking plate osteosynthesis
  • osteosynthesis
  • star-plate
  • arrow-plate
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with a fracture of the patellar, which were operated with a locking plate osteosynthesis in the Friederikenstift Hannover since May 2013.

Inclusion criteria

  • patients with indication for operative treatment of a patellar fracture
  • sufficient compliance
  • signed patient information

Exclusion criteria

Exclusion Criteria:

  • preoperative disease or trauma of the patellar
  • preoperative loss of motion of the knee
  • former operations of the patellar
  • alcohol or drug consumption
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Clinical short-term results

    The clinical short-term results after treating a patellar fracture with plate osteosynthesis are evaluated. Therefore functional motion is measured, complications and revision operations reviewed and knee-scores analyzed (Tegner-Score, Lysholm-Score, Kujala-Score, International Knee Documentation Committee - Subjective knee evaluation form).

    Time frame: 6 weeks

Secondary outcomes

  1. Clinical long-term results

    Further changes in functional motion and knee-scores are analyzed as well as the occurrence and frequency of complications and revision operations.

    Time frame: 24 months

06

Study locations

1 site
  • Diakoniekrankenhaus Friederikenstift Hannover
    Hannover, Niedersachsen 20169, Germany
07

References and documents

Publications

  • Ellwein A, Lill H, DeyHazra RO, Smith T, Katthagen JC. Outcomes after locked plating of displaced patella fractures: a prospective case series. Int Orthop. 2019 Dec;43(12):2807-2815. doi: 10.1007/s00264-019-04337-7. Epub 2019 Apr 30. PubMed 31041522 ↗
08

Registry details

Key details

Study ID
NCT02015975
Lead sponsor
Diakoniekrankenhaus Friederikenstift
Responsible party
Sponsor
First posted
Dec 19, 2013
Start date
May 1, 2013
Primary completion
Mar 31, 2018
Completion
Jun 30, 2018
Last update
Jul 26, 2018

Study contacts

Alexander Ellwein, Dr.
principal investigator · Friederikenstift Hannover

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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