bicruciate-retaining total knee arthroplasty for Knee
Phase-Based Progress Estimates
Effectiveness
Safety
Centre Hospitalier de l'Université de Montréal, Montréal, Canada
Knee+3 More
bicruciate-retaining total knee arthroplasty - ProcedureEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
Total knee arthroplasty (TKA) with the sacrifice of the anterior cruciate ligament is the standard treatment for severe knee osteoarthritis. A number of studies on the kinematics of the prosthetic knee tend to show that implants that preserve the cruciate ligaments best reproduce the kinematics of the healthy knee. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis. Method: Randomized controlled trial Monocentric Randomization will be done using sealed envelopes
Eligible Conditions
- Knee
- Total Knee Arthroplasty (TKA)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 30 Secondary · Reporting Duration: Change from baseline (pre surgery) MARX score at 10 yearss after the surgery
Year 1
Changes in 3D knee kinematics assessment during walking - knee flexion and extension
Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee abduction and adduction
Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee internal and external rotation
Year 10
Change in Knee ligament laxity : Anterior/Posterior Instability
Year 2
Change in Body Mass Index (BMI)
Year 1
Change in EOS imaging pseudo-kinematic - free squatting task - knee abduction and adduction
Change in EOS imaging pseudo-kinematic - free squatting task - knee flexion and extension
Change in EOS imaging pseudo-kinematic - free squatting task - knee internal and external rotation
Change in EOS imaging pseudo-kinematic - standardized squatting task - knee abduction and adduction
Change in EOS imaging pseudo-kinematic - standardized squatting task - knee flexion and extension
Change in EOS imaging pseudo-kinematic - standardized squatting task - knee internal and external rotation
Year 10
Change in Knee alignment : Hip-knee-ankle (HKA)
Year 10
Change in Knee alignment : Hip-knee-shaft (HKS)
Year 10
Change in International Knee Society scoring system (IKS) : knee score
Year 10
Change in International Knee Society scoring system (IKS) : function score
Year 10
Change in KOOS activity of daily living score
Year 5
Change in KOOS pain score
Year 10
Change in KOOS symptoms score
Year 10
Change in KOOS quality of life score
Year 10
Change in KOOS sport and recreation score
Year 10
Change in Lower limb morphology in the coronal plane
Year 10
Change in MARX score
Year 10
Change in Knee alignment : Medial distal femoral angle (MDFA)
Year 10
Change in Knee alignment : Medial proximal tibial angle (MPTA)
Year 10
Change in Knee ligament laxity : Medial/Lateral Instability
Year 10
Change in Patellar apprehension test
Year 10
Change in Physical Activities Scale
Year 10
Change in Physical Activity Level Scale
Year 10
Change in Knee Range of Motion (ROM)
Year 10
Change in 12-Item Short Form Survey (SF-12) score
Year 1
Change in TELOS radiological laximetry
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
posterior-stabilized total knee arthroplasty
1 of 2
bicruciate-retaining total knee arthroplasty
1 of 2
Active Control
Experimental Treatment
77 Total Participants · 2 Treatment Groups
Primary Treatment: bicruciate-retaining total knee arthroplasty · No Placebo Group · N/A
bicruciate-retaining total knee arthroplasty
Procedure
Experimental Group · 1 Intervention: bicruciate-retaining total knee arthroplasty · Intervention Types: Procedureposterior-stabilized total knee arthroplasty
Procedure
ActiveComparator Group · 1 Intervention: posterior-stabilized total knee arthroplasty · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline (pre surgery) marx score at 10 yearss after the surgery
Closest Location: Centre Hospitalier de l'Université de Montréal · Montréal, Canada
2012First Recorded Clinical Trial
0 TrialsResearching Knee
50 CompletedClinical Trials
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
319 Previous Clinical Trials
112,172 Total Patients Enrolled
Frédéric Lavoie, MD, M.ScPrincipal InvestigatorCHUM
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a coronal knee malalignment of 10 degrees or less.
You have a range of motion of 10 degrees or more.
The surgeon has adequate knee exposure to allow preservation of both cruciate ligaments.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Markolf, Keith L., Geoffery O'Neill, Steven R. Jackson, and David R. McAllister. 2004. “Effects of Applied Quadriceps and Hamstrings Muscle Loads on Forces in the Anterior and Posterior Cruciate Ligaments”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546503262198.
- Komistek, Richard D., Jerome Allain, Dylan T. Anderson, Douglas A. Dennis, and Daniel Goutallier. 2002. “In Vivo Kinematics for Subjects with and Without an Anterior Cruciate Ligament”. Clinical Orthopaedics and Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00003086-200211000-00047.
- Komistek, Richard D., Richard D. Scott, Douglas A. Dennis, David Yasgur, Dylan T. Anderson, and Mary E. Hajner. 2002. “In Vivo Comparison of Femorotibial Contact Positions for Press-fit Posterior Stabilized and Posterior Cruciate–retaining Total Knee Arthroplasties”. The Journal of Arthroplasty. Elsevier BV. doi:10.1054/arth.2002.29329.
- Lee, Sang Yang, Nobuzo Matsui, Masahiro Kurosaka, Richard D Komistek, Mohamed Mahfouz, Douglas A Dennis, and Shinichi Yoshiya. 2005. “A Posterior-stabilized Total Knee Arthroplasty Shows Condylar Lift-off During Deep Knee Bends”. Clinical Orthopaedics and Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.blo.0000155013.31327.dc.
- Pradhan, N.R., L. Bale, P. Kay, and M.L. Porter. 2004. “Salvage Revision Total Knee Replacement Using the Endo-model® Rotating Hinge Prosthesis”. The Knee. Elsevier BV. doi:10.1016/j.knee.2004.03.001.
- Goutallier, D., O. Manicom, and S. Van Driessche. 2008. “Prothèse totale de genou hermès™ conservant les deux ligaments croisés : comparaison avec la version postérostabilisée au recul de huit ans”. Revue de chirurgie orthopédique et réparatrice de l'appareil moteur. Elsevier BV. doi:10.1016/j.rco.2008.04.012.
- Henckel, J., R. Richards, K. Lozhkin, S. Harris, F. M. Rodriguez y Baena, A. R. W. Barrett, and J. P. Cobb. 2006. “Very Low-dose Computed Tomography for Planning and Outcome Measurement in Knee Replacement”. The Journal of Bone and Joint Surgery. British Volume. British Editorial Society of Bone & Joint Surgery. doi:10.1302/0301-620x.88b11.17986.
- Furnes, Ove, Birgitte Espehaug, Stein Atle Lie, Stein Emil Vollset, Lars Birger Engesaeter, and Leif Ivar Havelin. 2002. “Early Failures Among 7,174 Primary Total Knee Replacements: A Follow-up Study from the Norwegian Arthroplasty Register 1994-2000”. Acta Orthopaedica Scandinavica. Medical Journals Sweden AB. doi:10.1080/000164702753671678.
- Thomsen, Morten G, Roshan Latifi, Thomas Kallemose, Kristoffer W Barfod, Henrik Husted, and Anders Troelsen. 2016. “Good Validity and Reliability of the Forgotten Joint Score in Evaluating the Outcome of Total Knee Arthroplasty”. Acta Orthopaedica. Informa UK Limited. doi:10.3109/17453674.2016.1156934.
- Laskin, Richard S.. 2005. “Choosing Your Implant”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2005.03.012.
- van den Bekerom, Michel, Thomas Patt, Miriam Kleinhout, Harm van der Vis, and G.H. Albers. 2010. “Early Complications After High Tibial Osteotomy –a Comparison of Two Techniques”. Journal of Knee Surgery. Georg Thieme Verlag KG. doi:10.1055/s-0030-1247797.
- Frédéric Lavoie 2011. "Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469776.
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