Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty

NCT06124651 | Completed

• 1 other identifier: tka_cr_ps
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee; Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (1)

• Improvement in Knee Society Knee Score

  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.

  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 (1)

• 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.

Study Arms (2)

CR knee

ACTIVE COMPARATOR

This type of total knee arthroplasty retains the posterior cruciate ligament.

Procedure: Total knee replacement with cruciate retaining femoral component

PS knee

ACTIVE COMPARATOR

This type of total knee sacrifices the posterior cruciate ligament and cam and post mechanism replaces its function.

Procedure: Total knee replacement with cruciate substituting femoral component

Interventions

Total knee replacement with cruciate retaining femoral component PROCEDURE

To perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate a metallic implants. Implants are fixed to patients' bone with bone cements. Many designs for femoral component designs are available. In the present study, two types of implants, one CR(cruciate retaining), where the posterior cruciate ligaments are retained, and one PS(Posterior cruciate substituting), where the posterior cruciate ligaments are resected, will be compared. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component design remains the same and the tibial component remains the same. Only the cruciate ligament parts are different. For this arm of intervention, CR knee will be used, so posterior cruciate will remain intact after the surgery and still function to aid in the knee stability.

CR knee

Total knee replacement with cruciate substituting femoral component PROCEDURE

To perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate metallic implants that has similar contours of a native knee. Implants are fixed to patients' bone with bone cements. This procedure will use the femoral component that sacrifice the posterior cruciate ligament and having a box area with a post, so that "cam-post" mechanism of implants can mimic the function of the posterior cruciate ligament. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component remains the same. The tibial component will remain the same design. Therefore, only the cruciate ligament parts will be different.

PS knee

Eligibility Criteria

• Age: 25 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Young Hoo Kim, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2004
• Primary Completion: June 30, 2006
• Study Completion: May 16, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11