Back to resultsSubstitution of the PCL in TKA With UC or PS Design
Primary Purpose
Patient Reported Outcome, Knee Osteoarthritis, Knee Arthroplasty
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TKA
Sponsored by
About this trial
This is an interventional treatment trial for Patient Reported Outcome
Eligibility Criteria
Inclusion Criteria:
- scheduled for TKA
Exclusion Criteria:
- higher constraint needed
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
UC
PS
Arm Description
Total Knee Arthroplasty with an ultracongruent insert
Total Knee Arthroplasty with posterior stabilized design
Outcomes
Primary Outcome Measures
ROM
Range of motion
Patient reported outcome
Oxford Knee Score min 0 points (worst), max 48 points (best)
Secondary Outcome Measures
Full Information
NCT ID
NCT04679857
First Posted
December 17, 2020
Last Updated
March 23, 2022
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT04679857
Brief Title
Substitution of the PCL in TKA With UC or PS Design
Official Title
Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (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
RCT comparing UC and PS TKA
Detailed Description
RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Reported Outcome, Knee Osteoarthritis, Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UC
Arm Type
Experimental
Arm Description
Total Knee Arthroplasty with an ultracongruent insert
Arm Title
PS
Arm Type
Active Comparator
Arm Description
Total Knee Arthroplasty with posterior stabilized design
Intervention Type
Other
Intervention Name(s)
TKA
Intervention Description
Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
ROM
Description
Range of motion
Time Frame
10 years
Title
Patient reported outcome
Description
Oxford Knee Score min 0 points (worst), max 48 points (best)
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for TKA
Exclusion Criteria:
higher constraint needed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Lützner
Organizational Affiliation
University Hospital Carl Gustav Carus, TU Dresden
Official's Role
Principal Investigator
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
Plan to Share IPD
No
Learn more about this trial
Substitution of the PCL in TKA With UC or PS Design
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