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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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