Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

N/AActive Not RecruitingNCT03873363

Technische Universität Dresden140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Knee Osteoarthritis

Interventions

PS TKADEVICE

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

CR TKADEVICE

Implantation of a cruciate retaining Total Knee Arthroplasty.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Knee Flexion

Knee flexion measured using a goniometer

Time frame: 1 year after surgery

Secondary Outcomes

Function assessed by the Knee Society Score

Knee Society Score

Time frame: 10 years after surgery

Patient Reported Outcome

Oxford Knee Score

Time frame: 10 years after surgery

Health-related Quality of Life

EQ-5D-3L

Time frame: 10 years after surgery

Activity assessed by UCLA activity score

UCLA activity score

Time frame: 10 years after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.