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
  • Other: TKA
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

  1. ROM [10 years]

    Range of motion

  2. 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:

Study Results

No Results Posted as of Apr 4, 2022