Is Second Knee at Risk During Simultaneous Bilateral Tota... | NCT04367272

Studies
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

NCT04367272

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

Apr 30, 2020Actual

Enrollment

163Estimated

Phase

Not Applicable

Conditions

Osteoarthritis, Knee
Infection
Periprosthetic Fracture Around Prosthetic Joint Implant

Interventions

First Arthroplasty
Second Arthroplasty

Countries

Not provided

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Estimated

Primary Completion Date

May 15, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Apr 25, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 29, 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

Apr 29, 2020

Last Update Posted Date

Apr 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Orkhan Aliyev, Residents Doctor in Orthopedics Department, Principal Investigator, Bezmialem Vakif UniversityPrincipal Investigator

Lead Sponsor

Bezmialem Vakif UniversityOTHER

Collaborators

Not provided

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

The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

Detailed Description

The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.

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

163Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First Knee	Active Comparator	The first knee is the knee where the surgery will begin to be applied.	Procedure: First Arthroplasty
Second Knee	Experimental	The second knee is the knee where the surgeon will apply secondly.	Procedure: Second Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
First Arthroplasty	Procedure	First Knee	First Knee
Second Arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local complications	Local operation related complications rate	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary bilateral knee osteoarthritis with refractory to conservative treatment
Patients who accept participation in the research and the randomization

Exclusion Criteria:

no history of malignancy
less than 75 years old
severe cardiac insufficiency and morbid obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orkhan Aliyev, MD	Contact	+905059917419		orkhanaliyev@outlook.com.tr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D007239	Infections

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided