Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: CR TKA; Device: PS TKA

• Registration Number: NCT03873363
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Primary Completion: 2020-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CR	CR TKA	Implantation of a cruciate retaining Total Knee Arthroplasty.
PS	PS TKA	Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.

Primary Outcome Measures

Name	Time	Method
Knee Flexion	1 year after surgery	Knee flexion measured using a goniometer

Secondary Outcome Measures

Name	Time	Method
Function assessed by the Knee Society Score	10 years after surgery	Knee Society Score
Patient Reported Outcome	10 years after surgery	Oxford Knee Score
Health-related Quality of Life	10 years after surgery	EQ-5D-3L
Activity assessed by UCLA activity score	10 years after surgery	UCLA activity score

Trial Locations

Locations (1)

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden; 🇩🇪 Dresden, Saxonia, Germany