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

NCT05469776 | Active Not Recruiting

• 1 other identifier: 10.068
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis

Keywords

bicruciate-retaining; posterior-stabilized; Total Knee Arthroplasty; Knee Osteoarthritis; kinematic

Outcome Measures

Primary Outcomes (1)

• Change in KOOS pain score

  KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems

  Change from baseline (pre surgery) KOOS pain score at 10 years after the surgery

Secondary Outcomes (129)

• Change in KOOS pain score

  Change from baseline (pre surgery) KOOS pain score at 6 weeks after the surgery

• Change in KOOS pain score

  Change from baseline (pre surgery) KOOS pain score at 6 months after the surgery

• Change in KOOS pain score

  Change from baseline (pre surgery) KOOS pain score at 1 year after the surgery

• Change in KOOS pain score

  Change from baseline (pre surgery) KOOS pain score at 2 years after the surgery

• Change in KOOS pain score

  Change from baseline (pre surgery) KOOS pain score at 5 years after the surgery

Other Outcomes (4)

• Change in Body Mass Index (BMI)

  Change from baseline (pre surgery) BMI at 6 weeks after the surgery

• Change in Body Mass Index (BMI)

  Change from baseline (pre surgery) BMI at 6 months after the surgery

• Change in Body Mass Index (BMI)

  Change from baseline (pre surgery) BMI at 1 year after the surgery

Study Arms (2)

bicruciate-retaining total knee arthroplasty

EXPERIMENTAL

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

Procedure: bicruciate-retaining total knee arthroplasty

posterior-stabilized total knee arthroplasty

ACTIVE COMPARATOR

The prosthesis requires the excision of both cruciate ligaments

Procedure: posterior-stabilized total knee arthroplasty

Interventions

bicruciate-retaining total knee arthroplasty PROCEDURE

bicruciate-retaining total knee arthroplasty

posterior-stabilized total knee arthroplasty PROCEDURE

posterior-stabilized total knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients awaiting a total knee replacement who are candidates for a bi-cruciate retaining prosthesis
• Disabling bicompartmental gonarthrosis with failure of conservative treatment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Related Publications (11)

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

  PMID: 1959288 BACKGROUND

• 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.

  PMID: 18929754 BACKGROUND

• 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.

  PMID: 1792876 BACKGROUND

• 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.

  PMID: 17075100 BACKGROUND

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

  PMID: 3967412 BACKGROUND

• 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.

  PMID: 2805470 BACKGROUND

• 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.

  PMID: 12439275 BACKGROUND

• 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.

  PMID: 11847622 BACKGROUND

• 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.

  PMID: 15991119 BACKGROUND

• 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.

  PMID: 15930936 BACKGROUND

• 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.

  PMID: 18300676 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frédéric Lavoie, MD, M.Sc

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 22, 2022
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)