Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03873363

Enrollment

140

Registered

2019-03-13

Start date

2018-04-01

Completion date

2030-09-01

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design

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.

Interventions

DEVICEPS TKA

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

DEVICECR TKA

Implantation of a cruciate retaining Total Knee Arthroplasty.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

No masking

Intervention model description

Randomization to one of two surgical techniques.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Knee Flexion	1 year after surgery	Knee flexion measured using a goniometer

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Adverse Events	1 year after surgery	Adverse Events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026