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

February 16, 2017 updated by: Guangdong Chen, Cangzhou Central Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital for Special Surgery Knee Score
Time Frame: changes of baseline, postoperative month 3 and month 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lysholm Knee Scoring Scale
Time Frame: changes of baseline, postoperative month 3 and month 12
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
Time Frame: changes of postoperative month 3 and month 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cangzhou Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guangdong Chen, Master, Cangzhou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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