NCT05701592

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2022Dec 2026

Study Start

First participant enrolled

December 20, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 9, 2023

Last Update Submit

January 25, 2023

Conditions

Posterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (8)

  • The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    At the 12 month of the follow-up.

  • The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    At the 24 month of the follow-up.

  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

    At the 12 month of the follow-up.

  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

    At the 24 month of the follow-up.

  • Retear rate

    At the 12 month of the follow-up.

  • +3 more secondary outcomes

Study Arms (1)

Patients with PCL tear treated with DB-PCLR

Patients with PCL tear treated with DB-PCLR

Procedure: DB-PCLR

Interventions

DB-PCLRPROCEDURE

DB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed.

Patients with PCL tear treated with DB-PCLR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after PCL tear with knee instability undergoing DB-PCLR

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28866340BACKGROUND

  • 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.

    PMID: 36209443BACKGROUND

  • 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.

    PMID: 29953296BACKGROUND

  • 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.

    PMID: 30657698BACKGROUND

Study Officials

  • Konrad Malinowski, MD PhD

    Artromedical Orthopaedic Clinic, Bełchatów, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212malwin8@wp.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 27, 2023

Study Start

December 20, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

PL(1)