Back to resultsClinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay
Primary Purpose
Knee Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PS TKA
CR TKA
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design
Eligibility Criteria
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
Sites / Locations
- University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PS
CR
Arm Description
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Implantation of a cruciate retaining Total Knee Arthroplasty.
Outcomes
Primary Outcome Measures
Knee Flexion
Knee flexion measured using a goniometer
Secondary Outcome Measures
Function assessed by the Knee Society Score
Knee Society Score
Patient Reported Outcome
Oxford Knee Score
Health-related Quality of Life
EQ-5D-3L
Activity assessed by UCLA activity score
UCLA activity score
Full Information
NCT ID
NCT03873363
First Posted
March 7, 2019
Last Updated
August 20, 2021
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT03873363
Brief Title
Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay
Official Title
Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
September 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to one of two surgical techniques.
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PS
Arm Type
Experimental
Arm Description
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Arm Title
CR
Arm Type
Active Comparator
Arm Description
Implantation of a cruciate retaining Total Knee Arthroplasty.
Intervention Type
Device
Intervention Name(s)
PS TKA
Intervention Description
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Intervention Type
Device
Intervention Name(s)
CR TKA
Intervention Description
Implantation of a cruciate retaining Total Knee Arthroplasty.
Primary Outcome Measure Information:
Title
Knee Flexion
Description
Knee flexion measured using a goniometer
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Function assessed by the Knee Society Score
Description
Knee Society Score
Time Frame
10 years after surgery
Title
Patient Reported Outcome
Description
Oxford Knee Score
Time Frame
10 years after surgery
Title
Health-related Quality of Life
Description
EQ-5D-3L
Time Frame
10 years after surgery
Title
Activity assessed by UCLA activity score
Description
UCLA activity score
Time Frame
10 years after surgery
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse Events
Time Frame
1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay
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