Substitution of the PCL in TKA With UC or PS Design
Sponsor
Technische Universität Dresden (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04679857
Collaborator
(none)
127
1
2
157.9
0.8
Study Details
Study Description
Brief Summary
RCT comparing UC and PS TKA
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament
Study Design
Study Type:
Interventional
Actual Enrollment
:
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design
Actual Study Start Date
:
Nov 1, 2012
Anticipated Primary Completion Date
:
Mar 30, 2025
Anticipated Study Completion Date
:
Dec 30, 2025
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: UC Total Knee Arthroplasty with an ultracongruent insert |
Other: TKA
Total Knee Arthroplasty
|
Active Comparator: PS Total Knee Arthroplasty with posterior stabilized design |
Other: TKA
Total Knee Arthroplasty
|
Outcome Measures
Primary Outcome Measures
- ROM [10 years]
Range of motion
- Patient reported outcome [10 years]
Oxford Knee Score min 0 points (worst), max 48 points (best)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- scheduled for TKA
Exclusion Criteria:
- higher constraint needed
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden | Dresden | Saxonia | Germany | 01307 |
Sponsors and Collaborators
- Technische Universität Dresden
Investigators
- Principal Investigator: Jörg Lützner, University Hospital Carl Gustav Carus, TU Dresden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT04679857
Other Study ID Numbers:
- TKA UC PS
First Posted:
Dec 22, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: