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

Posterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701592
• Other study ID #: 2-pro-ar-2023
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509812212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posterior Cruciate Ligament Tear

Intervention

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

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
Konrad Malinowski MD

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Retear rate	Rate of patients with retear of the reconstructed ligament	At the 12 month of the follow-up.
Secondary	Retear rate	Rate of patients with retear of the reconstructed ligament	At the 24 month of the follow-up.
Secondary	ROM	Knee range of motion assessed by the means of goniometer.	At the 12 month of the follow-up.
Secondary	ROM	Knee range of motion assessed by the means of goniometer.	At the 24 month of the follow-up.