Comparison Of Outcomes After Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses

Total Knee Arthroplasty Clinical Trial

Official title:

Comparison Of Outcomes After Bilateral Simultaneous Total Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06170931
• Other study ID #: IRB00013890
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 1, 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• posterior cruciate ligament-retaining prostheses
Posterior cruciate ligament protective approach in patients with knee osteoarthritis
• posterior cruciate ligament-substituting prostheses
Posterior cruciate ligament transection approach in patients with knee osteoarthritis

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motions	Preoperative and postoperative knee flexion and extension degrees of the patients were measured.	3 year
Secondary	WOMAC Score (Score from 0 to 100)	Preoperative and postoperative WOMAC score of the patients were examined.	3 year
Secondary	OXFORD Knee Score(Score from 0 to 60)	Preoperative and postoperative OXFORD score of the patients were examined.	3 year