Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

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

Posterior cruciate ligament replacement knee prostheses or posterior-stabilized (PS) are the most used type of prosthesis. Various studies of the kinematics of the prosthetic knee tend to show that implants that preserve both cruciate ligaments best reproduce the kinematics of the healthy knee. These implants are the unicondylar knee Arthroplasty - in which only one side of the femorotibial joint is replaced; most often the medial side - and the bicruciate-retaining total knee arthroplasty (BCR). The BCR prosthesis is perceived as technically difficult to install and has never been a great commercial success despite the scientific demonstration of its virtues for knee kinematics. Given the current trend among prosthetic implant manufacturers to optimize the performance of knee prostheses for younger, active patients, the retention of both cruciate ligaments appears to be an interesting alternative. Unfortunately, there are no good studies comparing the results of the BCR prosthesis to the PS prosthesis. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used (BCR vs PS). The hypothesis is that the BCR prosthesis will result in better function of the operated knee than the PS prosthesis, resulting in joint kinematics closer to a healthy knee, better clinical scores and a higher activity level. 60 patients undergoing a total knee arthroplasty will be recruited. Randomization will be done intraoperatively using sealed envelopes once the indication for BCR TKA has been definitively established. Demographic data, medical history, clinical assessment and 4 questionnaires (IKS, KOOS, Marx and SF-12) will be completed prior to surgery. A standard x-ray, EOS imaging, TELOS radiological laximetry and a non-invasive evaluation of the 3D kinematics will be performed before the surgery. Patients will complete the 4 questionnaires at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post-surgery. A standard radiological examination will be performed at the same follow-ups. TELOS radiological laximetry, EOS imaging and 3D kinematics assessment will be repeated at the 1-year follow-up post-surgery.

The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 weeks after the surgery

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 months after the surgery

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 1 year after the surgery

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 2 years after the surgery

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 5 years after the surgery

Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 10 years after the surgery

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

TELOS radiological laximetry of both knees; varus and valgus laxity with knees in extension, anterior-posterior laxity of the knees at 20 and 90 degrees of flexion

EOS imaging of both knees during a standardized squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees

EOS imaging of both knees during a standardized squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees

Change in EOS imaging pseudo-kinematic - standardized squatting task - knee internal and external rotation

EOS imaging of both knees during a standardized squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees

EOS imaging of both knees during a free squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees

EOS imaging of both knees during a free squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees

EOS imaging of both knees during a free squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees

3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the media-lateral axis (knee flexion and extension), degrees

Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee abduction and adduction

3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the anteroposterior axis (knee abduction and adduction), degrees

Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee internal and external rotation

3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the longitudinal axis (knee internal and external rotation), degrees

Inclusion Criteria: Patients awaiting a total knee replacement who are candidates for a bi-cruciate retaining prosthesis Disabling bicompartmental gonarthrosis with failure of conservative treatment 70 years of age or younger at the time of the pre-operative consultation Intact and functional cruciate ligaments Coronal knee malalignment of 10 degrees or less Adequate preoperative range of motion, defined as maximum flexum (inability to fully extend the knee) of 10 degrees and flexion greater than 90 degrees Adequate intraoperative knee exposure to allow preservation of both cruciate ligaments Exclusion Criteria: Inability to undergo an EOS examination, defined as the inability to stand or morbid obesity (inability of the patient to enter the EOS machine, which is relatively cramped) Inability to walk on a treadmill and squat Pregnant women to avoid unnecessary fetal radiation Illiteracy, language barrier and any other reason that prevents patients from answering the questionnaires

Cloutier JM. Long-term results after nonconstrained total knee arthroplasty. Clin Orthop Relat Res. 1991 Dec;(273):63-5.

Goutallier D, Manicom O, Van Driessche S. [Total knee arthroplasty with bicruciate preservation: Comparison versus the same posterostabilized design at eight years follow-up]. Rev Chir Orthop Reparatrice Appar Mot. 2008 Oct;94(6):585-95. doi: 10.1016/j.rco.2008.04.012. Epub 2008 Jul 11. French.

Goutallier D, Glorion C. [Critical assessment of the functional advantage of preserving the 2 cruciate ligaments in total knee prosthesis. Experience with the Hermes' prosthesis]. Acta Orthop Belg. 1991;57 Suppl 2:128-9. No abstract available. French.

Henckel J, Richards R, Lozhkin K, Harris S, Rodriguez y Baena FM, Barrett AR, Cobb JP. Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol. J Bone Joint Surg Br. 2006 Nov;88(11):1513-8. doi: 10.1302/0301-620X.88B11.17986.

Insall JN, Binazzi R, Soudry M, Mestriner LA. Total knee arthroplasty. Clin Orthop Relat Res. 1985 Jan-Feb;(192):13-22.

Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

Komistek RD, Allain J, Anderson DT, Dennis DA, Goutallier D. In vivo kinematics for subjects with and without an anterior cruciate ligament. Clin Orthop Relat Res. 2002 Nov;(404):315-25. doi: 10.1097/00003086-200211000-00047.

Komistek RD, Scott RD, Dennis DA, Yasgur D, Anderson DT, Hajner ME. In vivo comparison of femorotibial contact positions for press-fit posterior stabilized and posterior cruciate-retaining total knee arthroplasties. J Arthroplasty. 2002 Feb;17(2):209-16. doi: 10.1054/arth.2002.29329.

Laskin RS. Choosing your implant: cemented, tricompartmental, and posterior stabilized. J Arthroplasty. 2005 Jun;20(4 Suppl 2):7-9. doi: 10.1016/j.arth.2005.03.012.

Lee SY, Matsui N, Kurosaka M, Komistek RD, Mahfouz M, Dennis DA, Yoshiya S. A posterior-stabilized total knee arthroplasty shows condylar lift-off during deep knee bends. Clin Orthop Relat Res. 2005 Jun;(435):181-4. doi: 10.1097/01.blo.0000155013.31327.dc.

van den Bekerom MP, Patt TW, Kleinhout MY, van der Vis HM, Albers GH. Early complications after high tibial osteotomy: a comparison of two techniques. J Knee Surg. 2008 Jan;21(1):68-74. doi: 10.1055/s-0030-1247797.