New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee
Primary Purpose
Tibial Fractures
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
new bone fixation plate with screw
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pathologic fracture
- Fracture accompanied by nerve injury
- Knee osteoarthritis
- Other chronic knee diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
new bone fixation plate with screw
Arm Description
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).
Outcomes
Primary Outcome Measures
Hospital for Special Surgery Knee Score
To evaluate knee function. The higher the score, the better the recovery of knee function is.
Secondary Outcome Measures
Lysholm Knee Scoring Scale
To evaluate knee function. The higher the score, the better the recovery of knee function is.
Patient satisfaction
The percentage of the number of patients with satisfactory knee function to the total number of cases. The higher the value, the more satisfied with the treatment plan.
Full Information
NCT ID
NCT03059368
First Posted
February 12, 2017
Last Updated
February 16, 2017
Sponsor
Cangzhou Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03059368
Brief Title
New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee
Official Title
New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee: a Prospective, Open-label, Self-controlled, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cangzhou Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
History and current related studies Posterior cruciate ligament of the knee is an important structure to maintain stability of the knee, and can prevent backward displacement of the tibia, so the violence that causes the tibia to move backward can cause posterior cruciate ligament rupture. Tibial avulsion fracture of posterior cruciate ligament of the knee will lead to unstable posterior movement and rotation of the knee and accelerate the degeneration of the knee. Thus, maintaining the tension of posterior cruciate ligament and restoring anatomical stability of the knee affect early rehabilitation and surgical treatment, and are the difficulty and key point of sports medicine.
When tibial avulsion fracture of posterior cruciate ligament of knee is treated with open reduction and rivet fixation, hollow screw fixation or arthroscopic reconstruction of the posterior cruciate ligament, plaster fixation is often required for flexion and extension exercises. However, the importance of early tension reconstruction of posterior cruciate ligament is often ignored. How to select the fixation method for tibial avulsion fracture of posterior cruciate ligament and how to restore the anatomical stability of the joint are still controversial. In recent years, with the development of surgical techniques and instruments and the popularization of the concept of precision surgical treatment, high requirements are put forward for the new fracture fixation methods.
Data collection, management, analysis, open access
Data collection: Case report forms will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
Data management: The locked electronic database will be accessible and locked only by the project manager. This arrangement will not be altered. The Cangzhou Central Hospital, China will preserve all of the data regarding this trial.
Data analysis: A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial that yields accurate and complete data.
Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
Statistical analysis will be performed using SPSS 13.0 software (SPSS, Chicago, IL, USA) and will follow the intention-to-treat principle. Normally distributed measurement data will be expressed as means ± standard deviation and minimums and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3). The count data will be expressed as a percentage.
Normally distributed data of HSS and Lysholm Knee Scoring Scale scores at preoperative, postoperative 3 and 12 months will be analyzed with one-way analysis of variance and least significant difference. Non-normally distributed data will be analyzed using Kruskall-Wills H test and Cohen's d test. Patient satisfaction and incidence of adverse reactions at postoperative 3 and 12 months will be compared using McNemar χ2 test. The significance level will be α = 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new bone fixation plate with screw
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
new bone fixation plate with screw
Intervention Description
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).
Primary Outcome Measure Information:
Title
Hospital for Special Surgery Knee Score
Description
To evaluate knee function. The higher the score, the better the recovery of knee function is.
Time Frame
changes of baseline, postoperative month 3 and month 12
Secondary Outcome Measure Information:
Title
Lysholm Knee Scoring Scale
Description
To evaluate knee function. The higher the score, the better the recovery of knee function is.
Time Frame
changes of baseline, postoperative month 3 and month 12
Title
Patient satisfaction
Description
The percentage of the number of patients with satisfactory knee function to the total number of cases. The higher the value, the more satisfied with the treatment plan.
Time Frame
changes of postoperative month 3 and month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pathologic fracture
Fracture accompanied by nerve injury
Knee osteoarthritis
Other chronic knee diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangdong Chen, Master
Organizational Affiliation
Cangzhou Central Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee
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