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Trial record 2 of 33 for:    Recruiting, Not yet recruiting, Available Studies | "Patella"

Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

This study is currently recruiting participants.
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Verified February 2016 by Diakoniekrankenhaus Friederikenstift
Information provided by (Responsible Party):
Diakoniekrankenhaus Friederikenstift Identifier:
First received: August 8, 2013
Last updated: February 14, 2016
Last verified: February 2016

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.

Fracture of Patella

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

Resource links provided by NLM:

Further study details as provided by Diakoniekrankenhaus Friederikenstift:

Primary Outcome Measures:
  • Clinical short-term results [ Time Frame: 6 weeks ]
    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).

Secondary Outcome Measures:
  • Clinical long-term results [ Time Frame: 24 months ]
    Further changes in functional motion and knee-scores are analyzed as well as the occurrence and frequency of complications and revision operations.

Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • preoperative disease or trauma of the patellar
  • preoperative loss of motion of the knee
  • former operations of the patellar
  • alcohol or drug consumption
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02015975

Contact: Alexander Ellwein, Dr. 00495111290

Diakoniekrankenhaus Friederikenstift Hannover Recruiting
Hannover, Niedersachsen, Germany, 20169
Contact: Alexander Ellwein, Dr.    00495111290   
Principal Investigator: Alexander Ellwein, Dr.         
Sponsors and Collaborators
Diakoniekrankenhaus Friederikenstift
Principal Investigator: Alexander Ellwein, Dr. Friederikenstift Hannover
  More Information

Responsible Party: Diakoniekrankenhaus Friederikenstift Identifier: NCT02015975     History of Changes
Other Study ID Numbers: 001-2013
Study First Received: August 8, 2013
Last Updated: February 14, 2016

Keywords provided by Diakoniekrankenhaus Friederikenstift:
patellar fracture
fracture of patella
locking plate osteosynthesis

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries processed this record on June 23, 2017