Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)

January 25, 2023 updated by: Konrad Malinowski MD
Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Anticipated)

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.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Konrad Malinowski, MD PhD
  • Phone Number: +48 509812212
  • Email: malwin8@wp.pl

Study Locations

  • Poland
    • Łódzkie
      • Bełchatów, Łódzkie, Poland, 97-400
        • Recruiting
        • Artromedical Orthopaedic Clinic
        • Contact:
          • Konrad Malinowski, MD PhD
          • Phone Number: +48 509 812 212
          • Email: malwin8@wp.pl

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients after PCL tear with knee instability undergoing DB-PCLR

Description

Inclusion Criteria:

  • PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically
  • full knee range of motion

Exclusion Criteria:

  • active knee inflammation
  • non-adherence to the study protocol
  • fixed posterior drawer

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients with PCL tear treated with DB-PCLR
Procedure: DB-PCLR
DB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed.

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
Knee posterior translatory stability - posterior sag test
Time Frame: At the 12 month of the follow-up.
Posterior sag test will be performed and outcome will be presented as present/ absent
At the 12 month of the follow-up.
Knee posterior translatory stability - posterior drawer test
Time Frame: At the 12 month of the follow-up.
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
At the 12 month of the follow-up.
Knee posterior translatory stability - posterior Lachman test
Time Frame: At the 12 month of the follow-up.
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
At the 12 month of the follow-up.
Knee posterior translatory stability - stress X-ray
Time Frame: At the 12 month of the follow-up.
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
At the 12 month of the follow-up.
Knee internal rotation stability
Time Frame: At the 12 month of the follow-up.
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
At the 12 month of the follow-up.
Knee posterior translatory stability - posterior sag test
Time Frame: At the 24 month of the follow-up.
Posterior sag test will be performed and outcome will be presented as present/ absent
At the 24 month of the follow-up.
Knee posterior translatory stability - posterior drawer test
Time Frame: At the 24 month of the follow-up.
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
At the 24 month of the follow-up.
Knee posterior translatory stability - posterior Lachman test
Time Frame: At the 24 month of the follow-up.
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
At the 24 month of the follow-up.
Knee posterior translatory stability - stress X-ray
Time Frame: At the 24 month of the follow-up.
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
At the 24 month of the follow-up.
Knee internal rotation stability
Time Frame: At the 24 month of the follow-up.
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
At the 24 month of the follow-up.

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
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time Frame: At the 12 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
At the 12 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time Frame: At the 24 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
At the 24 month of the follow-up.
Retear rate
Time Frame: At the 12 month of the follow-up.
Rate of patients with retear of the reconstructed ligament
At the 12 month of the follow-up.
Retear rate
Time Frame: At the 24 month of the follow-up.
Rate of patients with retear of the reconstructed ligament
At the 24 month of the follow-up.
ROM
Time Frame: At the 12 month of the follow-up.
Knee range of motion assessed by the means of goniometer.
At the 12 month of the follow-up.
ROM
Time Frame: At the 24 month of the follow-up.
Knee range of motion assessed by the means of goniometer.
At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: At the 12 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: At the 24 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
At the 24 month of the follow-up.

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.
Konrad Malinowski MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 20, 2022

Primary Completion (Anticipated)

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.
December 31, 2025

Study Completion (Anticipated)

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 31, 2026

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).
January 9, 2023

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.
January 25, 2023

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.
January 27, 2023

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.
January 27, 2023

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.
January 25, 2023

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.
January 1, 2023

More Information

Terms related to this study

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.
  • 2-pro-ar-2023

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings