Fracture of PatellaNCT02015975
Clinical Outcome After Treatment of Patellar Fractures With Locking Plates
An observational study of Fracture of Patella, run by Diakoniekrankenhaus Friederikenstift at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Patella
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2013to 30 Jun 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with indication for operative treatment of a patellar fracture
- sufficient compliance
- signed patient information
Who cannot join
- preoperative disease or trauma of the patellar
- preoperative loss of motion of the knee
- former operations of the patellar
- alcohol or drug consumption
Trial locations and contacts
1 site in 1 country.
Germany1 site
Diakoniekrankenhaus Friederikenstift Hannover
Hanover, Lower Saxony, 20169
About this study
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.
- Conditions
- Fracture of Patella
- Keywords
- patellar fracture, fracture of patella, patella, locking plate osteosynthesis, osteosynthesis, star-plate, arrow-plate
- Medical subject headings
- Patella Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start1 May 2013
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of PatellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Diakoniekrankenhaus Friederikenstift
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Ellwein, Dr., Principal investigator, Friederikenstift Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015975
- Sponsor's protocol ID
- 001-2013
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31041522
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Treatment of Patellar Fractures With Locking Plates
- ClinicalTrials.gov ID
- NCT02015975
- Acronym / sponsor ID
- 001-2013
- Conditions
- Fracture of Patella
- Keywords
- patellar fracture, fracture of patella, patella, locking plate osteosynthesis, osteosynthesis, star-plate, arrow-plate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Diakoniekrankenhaus FriederikenstiftUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with indication for operative treatment of a patellar fracture
- sufficient compliance
- signed patient information
Key exclusion criteria (4 listed)
- preoperative disease or trauma of the patellar
- preoperative loss of motion of the knee
- former operations of the patellar
- alcohol or drug consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Clinical long-term results
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 31041522Ellwein 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.
Related trials for Fracture of Patella
Active, not recruiting
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Patella Fracture
Not yet recruiting
Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
RecruitingObservational study
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Osteochondral Defect, Osteochondritis Dissecans
Active, not recruiting
Study of Knee Replacements for Patellofemoral Osteoarthritis
Osteoarthritis, Knee, Patellofemoral Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Ellwein, Dr. principal investigator
Friederikenstift Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Patella, run by Diakoniekrankenhaus Friederikenstift at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical short-term results (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.