New Bone Fixation Plate for the Repair of Tibial Avulsion Fracture of Posterior Cruciate Ligament of the Knee

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

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Device: new bone fixation plate with screw

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 58 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: new bone fixation plate with screw; 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).	Device: new bone fixation plate with screw; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital for Special Surgery Knee Score	To evaluate knee function. The higher the score, the better the recovery of knee function is.	changes of baseline, postoperative month 3 and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Knee Scoring Scale	To evaluate knee function. The higher the score, the better the recovery of knee function is.	changes of baseline, postoperative month 3 and month 12
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.	changes of postoperative month 3 and month 12

Collaborators and Investigators

• Sponsor: Cangzhou Central Hospital
• Investigators: Principal Investigator: Guangdong Chen, Master, Cangzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: February 12, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Fractures, Avulsion
• Other Study ID Numbers: CangzhouCH_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No