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RESEARCH ARTICLE
Year : 2017  |  Volume : 2  |  Issue : 1  |  Page : 18-23

New bone fixation plate for the repair of avulsion fracture of the tibial attachment of the posterior cruciate ligament: study protocol for a prospective, open-label, self-controlled, clinical trial


Cangzhou Central Hospital, Cangzhou, Hebei Province, China

Correspondence Address:
Guang-dong Chen
Cangzhou Central Hospital, Cangzhou, Hebei Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.201060

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Background: Avulsion fractures of the tibial attachment of the posterior cruciate ligament have been repaired using open reduction and rivet fixation, hollow screw fixation, or arthroscopic reconstruction of the posterior cruciate ligament. These methods ignore the importance of early tension reconstruction of the posterior cruciate ligament, so their efficacies are uncertain. Determining the optimal fixation method and how best to restore knee stability remain controversial. Methods/Design: We will conduct a prospective, single-center, self-controlled, clinical trial at the Cangzhou Central Hospital, Hebei Province, China. Fracture fragments and the injured posterior cruciate ligament will be exposed in twenty patients with avulsion fracture of the tibial attachment of the posterior cruciate ligament through a posterior approach and open reduction. The posterior cruciate ligament will be reconstructed with a new type of bone plate. All patients will be followed for 3 and 12 months. Primary outcome: The Hospital for Special Surgery knee score will be used to evaluate knee function preoperatively and 3 and 12 months postoperatively. Secondary outcomes: Lysholm Knee Scoring Scale, X-ray, computed tomography, and magnetic resonance imaging will be used to assess knee morphology preoperatively and 3 and 12 months postoperatively. Patient satisfaction will also be assessed at 3 and 12 months postoperatively. Discussion: This trial will evaluate a newly-designed plate fixation device for early tension reconstruction of the posterior cruciate ligament to repair avulsion fractures of the tibial attachment of the posterior cruciate ligament and restore knee stability. This trial will verify the plate's efficacy, provide an experimental basis for treating avulsion fractures of the tibial attachment of the posterior cruciate ligament, and provide a method of maximizing knee stability. Trial registration: ClinicalTrials.gov identifier: NCT03059368. Ethics: The study protocol has been approved by the Ethics Committee of Cangzhou Central Hospital of China. All protocols will be in accordance with Helsinki Declaration, formulated by the World Medical Association. Informed consent: Written informed consent will be provided by participants.


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