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

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: Recruiting
• Conditions: Posterior Cruciate Ligament Tear
• Intervention / Treatment: Procedure: DB-PCLR

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Knee posterior translatory stability - posterior sag test	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	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	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	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	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	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	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	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	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	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

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

Collaborators and Investigators

• Sponsor: Konrad Malinowski MD

Publications and helpful links

General Publications

• Chahla J, Moatshe G, Cinque ME, Dornan GJ, Mitchell JJ, Ridley TJ, LaPrade RF. Single-Bundle and Double-Bundle Posterior Cruciate Ligament Reconstructions: A Systematic Review and Meta-analysis of 441 Patients at a Minimum 2 Years' Follow-up. Arthroscopy. 2017 Nov;33(11):2066-2080. doi: 10.1016/j.arthro.2017.06.049. Epub 2017 Aug 31.
• Knapik DM, Gopinatth V, Jackson GR, Chahla J, Smith MV, Matava MJ, Brophy RH. Global variation in isolated posterior cruciate ligament reconstruction. J Exp Orthop. 2022 Oct 9;9(1):104. doi: 10.1186/s40634-022-00541-4.
• LaPrade RF, Cinque ME, Dornan GJ, DePhillipo NN, Geeslin AG, Moatshe G, Chahla J. Double-Bundle Posterior Cruciate Ligament Reconstruction in 100 Patients at a Mean 3 Years' Follow-up: Outcomes Were Comparable to Anterior Cruciate Ligament Reconstructions. Am J Sports Med. 2018 Jul;46(8):1809-1818. doi: 10.1177/0363546517750855.
• Bernhardson AS, DePhillipo NN, Aman ZS, Kennedy MI, Dornan GJ, LaPrade RF. Decreased Posterior Tibial Slope Does Not Affect Postoperative Posterior Knee Laxity After Double-Bundle Posterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Feb;47(2):318-323. doi: 10.1177/0363546518819786. Epub 2019 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID 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