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 / 中国组织工程研究

ABSTRACT

BACKGROUND:Avulsion fractures of the tibial attachment of the posterior cruciate ligament have been repaired using open reduction and rivet fixation, hol ow 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 wil conduct a prospective, single-center, self-control ed, clinical trial at the Cangzhou Central Hospital, Hebei Province, China. Fracture fragments and the injured posterior cruciate ligament wil 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 wil be reconstructed with a new type of bone plate. Al patients wil be fol owed for 3 and 12 months. Primary outcome:The Hospital for Special Surgery knee score wil 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 wil be used to assess knee morphology preoperatively and 3 and 12 months postoperatively. Patient satisfaction wil 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. Al protocols wil be conducted in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent wil be provided by al participants. DISCUSSION:This trial wil 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 wil 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.