Clinical trial NCT06170931: Comparison Of Outcomes After Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses
Official title: Comparison Of Outcomes After Bilateral Simultaneous Total Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Knee
total knee arthroplasty
posterior cruciate ligament-substituting
posterior cruciate ligament-retaining
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.
Primary purpose: TREATMENT

Brief summary: Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Although there is no clear study suggesting which design is better, research on this subject has increased recently. the investigators aim is to define the superiority of these two designs over each other. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Detailed description: Total knee arthroplasty is used to treat patients with osteoarthritis, rheumatoid arthritis, and other knee disorders. Today, there are basically two primary designs; posterior cruciate Substituting (PS) and protects the posterior cruciate -Retaining (CR). However, it is still controversial which approach is good, as both CR and PS have advantages and disadvantages. Proponents of the posterior cruciate retaining system argue that it provides natural stability, wider joint range of motion, better proprioception, and better knee kinematics. In addition, proponents of the posterior cruciate substituting system argue that it provides more harmonious articulation and a wider flexion range.

As a result, although there is no clear study suggesting which design is better, research on this subject has increased recently. Our aim is to define the superiority of these two designs over each other.

Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Eligibility criteria: Inclusion Criteria:

1. Patients with primary osteoarthritis of both knees
2. Patients with secondary osteoarthritis of both knees

Exclusion Criteria:

1. Patients with primary osteoarthritis in both knees and undergoing unilateral knee prosthesis
2. Patients with secondary osteoarthritis in both knees and who underwent unilateral knee prosthesis
3. Patients with primary osteoarthritis in both knees and who underwent bilateral knee prosthesis in different sessions
4. Patients with secondary osteoarthritis in both knees and who underwent bilateral knee prosthetics in different sessions.

Primary outcomes:
measure: Range of motions
timeFrame: 3 year
Secondary outcomes:
measure: WOMAC Score (Score from 0 to 100)
timeFrame: 3 year
measure: OXFORD Knee Score(Score from 0 to 60)
timeFrame: 3 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Fatih
Study officials:
References:
citation: Li N, Tan Y, Deng Y, Chen L. Posterior cruciate-retaining versus posterior stabilized total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc. 2014 Mar;22(3):556-64. doi: 10.1007/s00167-012-2275-0. Epub 2012 Nov 3.
citation: Rossi R, Bruzzone M, Bonasia DE, Marmotti A, Castoldi F. Evaluation of tibial rotational alignment in total knee arthroplasty: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):889-93. doi: 10.1007/s00167-009-1023-6. Epub 2010 Jan 8.
citation: Insall JN, Lachiewicz PF, Burstein AH. The posterior stabilized condylar prosthesis: a modification of the total condylar design. Two to four-year clinical experience. J Bone Joint Surg Am. 1982 Dec;64(9):1317-23. No abstract available.
citation: In Y, Kim JM, Woo YK, Choi NY, Sohn JM, Koh HS. Factors affecting flexion gap tightness in cruciate-retaining total knee arthroplasty. J Arthroplasty. 2009 Feb;24(2):317-21. doi: 10.1016/j.arth.2007.10.022. Epub 2008 Oct 25.
citation: Chalidis BE, Sachinis NP, Papadopoulos P, Petsatodis E, Christodoulou AG, Petsatodis G. Long-term results of posterior-cruciate-retaining Genesis I total knee arthroplasty. J Orthop Sci. 2011 Nov;16(6):726-31. doi: 10.1007/s00776-011-0152-1. Epub 2011 Sep 10.
citation: Kim YH, Choi Y, Kwon OR, Kim JS. Functional outcome and range of motion of high-flexion posterior cruciate-retaining and high-flexion posterior cruciate-substituting total knee prostheses. A prospective, randomized study. J Bone Joint Surg Am. 2009 Apr;91(4):753-60. doi: 10.2106/JBJS.H.00805.