New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
To construct a self-designed plate fixation device for posterior cruciate ligament reconstruction, aim to verify its advantages on anatomical knee stability, so as to achieve fracture healing and keep tension after posterior cruciate ligament reconstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedFebruary 23, 2017
February 1, 2017
2.3 years
February 12, 2017
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital for Special Surgery Knee Score
To evaluate knee function. The higher the score, the better the recovery of knee function is.
changes of baseline, postoperative month 3 and month 12
Secondary Outcomes (2)
Lysholm Knee Scoring Scale
changes of baseline, postoperative month 3 and month 12
Patient satisfaction
changes of postoperative month 3 and month 12
Study Arms (1)
new bone fixation plate with screw
EXPERIMENTALFracture ends and injured posterior cruciate ligament will be exposed in twenty patients with tibial avulsion fracture of posterior cruciate ligament of knee through posterior approach. Open reduction will be conducted. The posterior cruciate ligament will be reconstructed with a new bone fixation plate with screw(cancellous bone screw).
Interventions
Fracture ends and injured posterior cruciate ligament will be exposed in twenty patients with tibial avulsion fracture of posterior cruciate ligament of knee through posterior approach. Open reduction will be conducted. The posterior cruciate ligament will be reconstructed with a new bone fixation plate with screw(cancellous bone screw).
Eligibility Criteria
You may qualify if:
- Tibial avulsion fracture of posterior cruciate ligament of knee
- Limitation of flexion and extension of knee, posterior drawer test (+)
- History of knee trauma
- An age of 35-58 years
- Irrespective of gender
- Signed informed consent
You may not qualify if:
- Pathologic fracture
- Fracture accompanied by nerve injury
- Knee osteoarthritis
- Other chronic knee diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guangdong Chen, Master
Cangzhou Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
February 12, 2017
First Posted
February 23, 2017
Study Start
August 1, 2013
Primary Completion
November 1, 2015
Study Completion
December 1, 2016
Last Updated
February 23, 2017
Record last verified: 2017-02