Fracture of Patella Clinical Trial
Official title:
Clinical Outcome After Treatment of Patellar Fractures With Locking Plates
NCT number | NCT02015975 |
Other study ID # | 001-2013 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2013 |
Est. completion date | June 30, 2018 |
Verified date | July 2018 |
Source | Diakoniekrankenhaus Friederikenstift |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Diakoniekrankenhaus Friederikenstift Hannover | Hannover | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
Diakoniekrankenhaus Friederikenstift |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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