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

NCT06170931 | Completed

• 1 other identifier: IRB00013890
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

Knee; total knee arthroplasty; posterior cruciate ligament-substituting; posterior cruciate ligament-retaining

Outcome Measures

Primary Outcomes (1)

• Range of motions

  Preoperative and postoperative knee flexion and extension degrees of the patients were measured.

  3 year

Secondary Outcomes (2)

• WOMAC Score (Score from 0 to 100)

  3 year

• OXFORD Knee Score(Score from 0 to 60)

  3 year

Study Arms (2)

A knee of a patient with osteoarthritis of both knees

ACTIVE COMPARATOR

Posterior cruciate ligament protective approach in patients with knee osteoarthritis

Procedure: posterior cruciate ligament-retaining prostheses

The other knee of a patient with osteoarthritis in both knees

ACTIVE COMPARATOR

Posterior cruciate ligament transection approach in patients with knee osteoarthritis

Procedure: posterior cruciate ligament-substituting prostheses

Interventions

posterior cruciate ligament-retaining prostheses PROCEDURE

Posterior cruciate ligament protective approach in patients with knee osteoarthritis

A knee of a patient with osteoarthritis of both knees

posterior cruciate ligament-substituting prostheses PROCEDURE

Posterior cruciate ligament transection approach in patients with knee osteoarthritis

The other knee of a patient with osteoarthritis in both knees

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary osteoarthritis of both knees
• Patients with secondary osteoarthritis of both knees

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 23117166 BACKGROUND

• 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.

  PMID: 20057997 BACKGROUND

• 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.

  PMID: 7142239 BACKGROUND

• 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.

  PMID: 18951761 BACKGROUND

• 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.

  PMID: 21909722 BACKGROUND

• 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.

  PMID: 19339558 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 14, 2023
• Study Start: April 14, 2021
• Primary Completion: September 20, 2023
• Study Completion: July 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)