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

NCT ID: NCT05469776

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2031-12-31

Brief 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

Detailed Description

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.

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bicruciate-retaining total knee arthroplasty

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

Group Type: EXPERIMENTAL

bicruciate-retaining total knee arthroplasty

Intervention Type: PROCEDURE

posterior-stabilized total knee arthroplasty

The prosthesis requires the excision of both cruciate ligaments

Group Type: ACTIVE_COMPARATOR

posterior-stabilized total knee arthroplasty

Intervention Type: PROCEDURE

Interventions

bicruciate-retaining total knee arthroplasty

Intervention Type: PROCEDURE

posterior-stabilized total knee arthroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Frédéric Lavoie

Orthopedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frédéric Lavoie, MD, M.Sc

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

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

Reference Type: BACKGROUND

PMID: 1959288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18929754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1792876 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 3967412 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 2805470 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 15991119 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15930936 (View on PubMed)

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.

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Other Identifiers

10.068

Identifier Type: -

Identifier Source: org_study_id