Clinical trial NCT06124651: Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty
Official title: Clinical Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty in Same Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Arthropathy of Knee Joint
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Knee Society Knee Score
timeFrame: 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
Secondary outcomes:
measure: Improvement in the Range of motion
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Young Hoo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: