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

doi:10.3969/j.issn.2095-4344.2017.07.007

Abstract

Abstract:

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.

OBJECTIVE: To observe the stability of new bone fixation plate for the repair of avulsion fracture of the tibial attachment of the posterior cruciate ligament.

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 20 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. The study protaol was registered at clinicaltrials.gov.NCT03059368. The study protocol has been approved by the Ethics Committee of Cangzhou Central Hospital of China. All protocols will be conducted in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by all participants.

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.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Tibia, Knee Joint

CLC Number:

R318

Chen Guang-dong, Cao Tong-jun, Li Jian. 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 [J]. Chinese Journal of Tissue Engineering Research, 2017, 21(7): 1020-1024.

Figures/Tables 3

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