New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures; Fractures, Avulsion
Study type: Interventional

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

        1. 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.

        2. 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.

        3. 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.

        4. Data open access: Anonymized trial data will be published at www.figshare.com.

      Statistical analysis

        1. 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.

        2. 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.
    

Intervention name(s): new bone fixation plate with screw
Intervention type(s): Device
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment