Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Arthropathy of Knee Joint; Osteoarthritis, Knee
• Interventions: Procedure: Total knee replacement with cruciate retaining femoral component; Procedure: Total knee replacement with cruciate substituting femoral component

• Registration Number: NCT06124651
• Lead Sponsor: Ewha Womans University

Brief Summary

Several authors and large registries have suggested the potential for an increased risk of all-cause revision with the use of posterior cruciate-substitution (PS) total knee arthroplasty (TKA). The purpose of the current study was to compare posterior cruciate retaining (CR) and PS implants with respect to the functional and radiographic results, prevalence of osteolysis, revision rates and survivorship.

Detailed Description

The supremacy debate between posterior cruciate-retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA) has now entered into the 4th decade. Multiple research studies have investigated CR and PS TKAs on the basis of kinematic, clinical, radiographic, and survivorship analysis. Despite arguments in favor of CR or PS TKA designs, several short or mid-term studies have shown no difference in functional outcomes between these two designs. Considering the fact that CR and PS TKA fare equally at short-term and mid-term, the decision to select either design should depend on their long-term survivorship. There have been few long-term survivorship analysis that have directly compared CR and PS TKAs with aseptic revision for any reason as the end point.

These long-term studies of CR and PS TKA have been done independently. A comparison of the results in the same patients eliminates the variability that is introduced by differences in gender, age, weight, comorbidity, bone quality, and activity level and allows for a meaningful comparison of the impact of fixation on the outcome of TKA. However, variability in terms of the preoperative severity of arthritis cannot be eliminated because of the design on both sides is rarely identical.

The purpose of this study was to identify differences in implant survivorship between CR and PS TKAs in patients with osteoarthritis who were younger than 65 years of age and CR implant in one knee and PS implant in the other.

Study Timeline

• Study Start: 2004-01-01
• Primary Completion: 2006-06-30
• Study Completion: 2023-05-16
• Study First Submitted: 2023-08-23
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-04
• Last Update Submitted: 2023-11-04
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria

• Inflammatory disease
• patient with other Lower extremity disease which may affect functional outcome
• Neurologic disease effecting patients lower extremity
• Revision surgery
• Patient not medically cleared for bilateral surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CR knee	Total knee replacement with cruciate retaining femoral component	This type of total knee arthroplasty retains the posterior cruciate ligament.
PS knee	Total knee replacement with cruciate substituting femoral component	This type of total knee sacrifices the posterior cruciate ligament and cam and post mechanism replaces its function.

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	Initial(one day before surgery), at 3 months after the surgery, 1 year after the surgery, and then average 1 year after until the study completion	change in knee score will be compared with initial score, until mean follow up of 25 years. The score ranges from 0 to 100, and the 100 is the highest.

Secondary Outcome Measures

Name	Time	Method
Improvement in the Range of motion	Initial(one day before surgery), and at 3 months after the surgery, 1 year after the surgery, and then average 1year after surgery until the study completion.	change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.The range of motion for knee typically are around 0 degrees to 130 degrees, and more range is considered as a better outcome.