Substitution of the PCL in TKA With UC or PS Design | NCT04679857

Studies
Substitution of the PCL in TKA With UC or PS Design

NCT04679857

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Feb 20, 2024Actual

Enrollment

127Actual

Phase

Not Applicable

Conditions

Patient Reported Outcome
Knee Osteoarthritis
Knee Arthroplasty

Interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2012Actual

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Dec 17, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC	Experimental	Total Knee Arthroplasty with an ultracongruent insert	Other: TKA
PS	Active Comparator	Total Knee Arthroplasty with posterior stabilized design	Other: TKA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TKA	Other	Total Knee Arthroplasty	PS UC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ROM	Range of motion	10 years
Patient reported outcome	Oxford Knee Score min 0 points (worst), max 48 points (best)	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for TKA

Exclusion Criteria:

higher constraint needed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörg Lützner	University Hospital Carl Gustav Carus, TU Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden		Dresden	Saxony	01307	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided