Clinical trial NCT05701592: Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)
Official title: Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Posterior Cruciate Ligament Tear
Lead sponsor: Artromedical Konrad Malinowski Clinic
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after PCL tear with knee instability undergoing DB-PCLR

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.


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

Primary outcomes:
measure: Knee posterior translatory stability - posterior sag test
timeFrame: At the 12 month of the follow-up.
measure: Knee posterior translatory stability - posterior drawer test
timeFrame: At the 12 month of the follow-up.
measure: Knee posterior translatory stability - posterior Lachman test
timeFrame: At the 12 month of the follow-up.
measure: Knee posterior translatory stability - stress X-ray
timeFrame: At the 12 month of the follow-up.
measure: Knee internal rotation stability
timeFrame: At the 12 month of the follow-up.
measure: Knee posterior translatory stability - posterior sag test
timeFrame: At the 24 month of the follow-up.
measure: Knee posterior translatory stability - posterior drawer test
timeFrame: At the 24 month of the follow-up.
measure: Knee posterior translatory stability - posterior Lachman test
timeFrame: At the 24 month of the follow-up.
measure: Knee posterior translatory stability - stress X-ray
timeFrame: At the 24 month of the follow-up.
measure: Knee internal rotation stability
timeFrame: At the 24 month of the follow-up.
Secondary outcomes:
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 24 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At the 24 month of the follow-up.
measure: Retear rate
timeFrame: At the 12 month of the follow-up.
measure: Retear rate
timeFrame: At the 24 month of the follow-up.
measure: ROM
timeFrame: At the 12 month of the follow-up.
measure: ROM
timeFrame: At the 24 month of the follow-up.
Other outcomes:
Locations:
city: Bełchatów
country: Poland
facility: Artromedical Orthopaedic Clinic
state: Łódzkie
Study officials:
affiliation: Artromedical Orthopaedic Clinic, Bełchatów, Poland
name: Konrad Malinowski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.