NCT04679857

Brief Summary

RCT comparing UC and PS TKA

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

12.4 years

First QC Date

December 17, 2020

Last Update Submit

February 16, 2024

Conditions

Patient Reported OutcomeKnee OsteoarthritisKnee Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • ROM

    Range of motion

    10 years

  • Patient reported outcome

    Oxford Knee Score min 0 points (worst), max 48 points (best)

    10 years

Study Arms (2)

UC

EXPERIMENTAL

Total Knee Arthroplasty with an ultracongruent insert

Other: TKA

PS

ACTIVE COMPARATOR

Total Knee Arthroplasty with posterior stabilized design

Other: TKA

Interventions

TKAOTHER

Total Knee Arthroplasty

PSUC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for TKA

You may not qualify if:

  • higher constraint needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jörg Lützner

    University Hospital Carl Gustav Carus, TU Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 22, 2020

Study Start

November 1, 2012

Primary Completion

March 30, 2025

Study Completion

December 30, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)