Menu
Recruiting NCT05701592

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

— Observational Posterior Cruciate Ligament Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DB-PCLR.
Who it may be relevant to
Registry conditions: Posterior Cruciate Ligament Tear. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Knee posterior translatory stability - posterior sag test [Time frame: 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.]
  • Knee posterior translatory stability - posterior Lachman test [Time frame: 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.]
  • Knee internal rotation stability [Time frame: 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.]
  • Knee posterior translatory stability - posterior drawer test [Time frame: 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.]
  • Knee posterior translatory stability - stress X-ray [Time frame: At the 24 month of the follow-up.]
  • Knee internal rotation stability [Time frame: At the 24 month of the follow-up.]
Secondary outcome measures (8)
  • The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [Time frame: 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.]
  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 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.]
  • Retear rate [Time frame: At the 12 month of the follow-up.]
  • Retear rate [Time frame: At the 24 month of the follow-up.]
  • ROM [Time frame: At the 12 month of the follow-up.]
  • ROM [Time frame: At the 24 month of the follow-up.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Artromedical Orthopaedic Clinic — Bełchatów

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. PMID 28866340
  • 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 36209443
  • 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 29953296
  • 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 30657698

Identifiers

NCT: NCT05701592 · 2-pro-ar-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗