Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

Fracture of Patella Clinical Trial

Official title:

Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015975
• Other study ID #: 001-2013
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Diakoniekrankenhaus Friederikenstift
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture of Patella
• Fractures, Bone

Locations

Country	Name	City	State
Germany	Diakoniekrankenhaus Friederikenstift Hannover	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Diakoniekrankenhaus Friederikenstift

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 weeks
Secondary	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.	24 months