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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
Cangzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures

Eligibility Criteria

35 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 12, 2017
    Last Updated
    February 16, 2017
    Sponsor
    Cangzhou Central Hospital
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    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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