Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Diakoniekrankenhaus Friederikenstift
Sponsor:
Information provided by (Responsible Party):
Diakoniekrankenhaus Friederikenstift
ClinicalTrials.gov Identifier:
NCT02015975
First received: August 8, 2013
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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.


Condition
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Further changes in functional motion and knee-scores are analyzed as well as the occurrence and frequency of complications and revision operations.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT02015975

Contacts
Contact: Alexander Ellwein, Dr. 00495111290 alexander.ellwein@ddh-gruppe.de

Locations
Germany
Diakoniekrankenhaus Friederikenstift Hannover Recruiting
Hannover, Niedersachsen, Germany, 20169
Contact: Alexander Ellwein, Dr.    00495111290    alexander.ellwein@ddh-gruppe.de   
Principal Investigator: Alexander Ellwein, Dr.         
Sponsors and Collaborators
Diakoniekrankenhaus Friederikenstift
Investigators
Principal Investigator: Alexander Ellwein, Dr. Friederikenstift Hannover
  More Information

No publications provided

Responsible Party: Diakoniekrankenhaus Friederikenstift
ClinicalTrials.gov Identifier: NCT02015975     History of Changes
Other Study ID Numbers: 001-2013
Study First Received: August 8, 2013
Last Updated: December 14, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 01, 2014