NCT02015975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

August 8, 2013

Last Update Submit

July 24, 2018

Conditions

Keywords

patellar fracturefracture of patellapatellalocking plate osteosynthesisosteosynthesisstar-platearrow-plate

Outcome Measures

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).

    6 weeks

Secondary Outcomes (1)

  • Clinical long-term results

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakoniekrankenhaus Friederikenstift Hannover

Hanover, Lower Saxony, 20169, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Alexander Ellwein, Dr.

    Friederikenstift Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

December 19, 2013

Study Start

May 1, 2013

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations