Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty

Nanjing University

Status: Not yet enrolling

Conditions: Knee Arthropathy

Treatments: Device: CR prosthesis; Device: PS prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT06617819

2024-6668-01

Details and patient eligibility

About

Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 45-80 years, any gender, BMI < 35 kg/m2
2. Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
3. Inversion deformity ≤ 15°
4. Posterior cruciate ligament integrity

Exclusion criteria

1. History of knee surgery (ligament, osteotomy, etc.)
2. knee flexion<90°.
3. flexion contracture of one knee > 10°
4. Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
5. Posterior cruciate ligament injury
6. Those assessed to be intolerant of surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

experimental group

Experimental group

Description:

CR prosthesis for the left knee

Treatment:

Device: CR prosthesis

control group

Active Comparator group

Description:

PS prosthesis for the left knee

Treatment:

Device: PS prosthesis