Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Technische Universität Dresden

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Device: CR TKA; Device: PS TKA

Study type: Interventional

Funder types: Other

Identifiers

NCT03873363

TKA CR vs PS

Details and patient eligibility

About

Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Full description

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for TKA with a non-linked, bicondylar total knee replacement
• written informed consent

Exclusion criteria

• Chronic pain patients
• Neuromuscular Diseases
• general illnesses that make mobilisation more difficult and/or prevent follow-up
• Known posterior cruciate ligament insufficiency
• Need for a higher degree of linkage
• BMI over 40 kg/m²
• Study doctor, his family, employees or other dependent persons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

PS

Experimental group

Description:

Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.

Treatment:

Device: PS TKA

CR

Active Comparator group

Description:

Implantation of a cruciate retaining Total Knee Arthroplasty.

Treatment:

Device: CR TKA