Clinical Outcome After Total Knee Arthroplasty Using CR o... | NCT03873363

Studies
Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

NCT03873363

Sponsor

Technische Universität Dresden

Status

Active, not recruiting

Last Update Posted

Feb 20, 2024Actual

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

PS TKA
CR TKA

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

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Sep 1, 2030Estimated

First Submitted Date

Mar 7, 2019

First Submission Date that Met QC Criteria

Mar 12, 2019

First Posted Date

Mar 13, 2019Actual

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

Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Detailed Description

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

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

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PS	Experimental	Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.	Device: PS TKA
CR	Active Comparator	Implantation of a cruciate retaining Total Knee Arthroplasty.	Device: CR TKA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PS TKA	Device	Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.	PS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Flexion	Knee flexion measured using a goniometer	1 year after surgery

Secondary Outcomes

Measure	Description	Time Frame
Function assessed by the Knee Society Score	Knee Society Score	10 years after surgery
Patient Reported Outcome	Oxford Knee Score

Other Outcomes

Measure	Description	Time Frame
Adverse Events	Adverse Events	1 year after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for TKA with a non-linked, bicondylar total knee replacement
written informed consent

Exclusion Criteria:

Chronic pain patients
Neuromuscular Diseases
general illnesses that make mobilisation more difficult and/or prevent follow-up
Known posterior cruciate ligament insufficiency
Need for a higher degree of linkage
BMI over 40 kg/m²
Study doctor, his family, employees or other dependent persons

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

Not provided

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

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