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NCT03873363 Clinical Trial

Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Knee Osteoarthritis Clinical Trial

Official title:
Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03873363
Other study ID # TKA CR vs PS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date September 1, 2030

Study information
Verified date February 2024
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 140
Est. completion date September 1, 2030
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• PS TKA
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
• CR TKA
Implantation of a cruciate retaining Total Knee Arthroplasty.

Locations
Country Name City State
Germany University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden Dresden Saxonia

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other Adverse Events Adverse Events 1 year after surgery
Primary Knee Flexion Knee flexion measured using a goniometer 1 year after surgery
Secondary Function assessed by the Knee Society Score Knee Society Score 10 years after surgery
Secondary Patient Reported Outcome Oxford Knee Score 10 years after surgery
Secondary Health-related Quality of Life EQ-5D-3L 10 years after surgery
Secondary Activity assessed by UCLA activity score UCLA activity score 10 years after surgery
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