Synovectomy in Primary Total Knee Arthrplasty | NCT03778463

Studies
Synovectomy in Primary Total Knee Arthrplasty

NCT03778463

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Dec 19, 2018Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Arthroplasty, Replacement, Knee
Synovectomy

Interventions

Synovectomy

Countries

Egypt

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 19, 2018Actual

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

Dec 14, 2018

Last Update Posted Date

Dec 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.

Detailed Description

Not provided

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synovectomy	Experimental		Other: Synovectomy
No synovectomy	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synovectomy	Other	Removal of the synovium during total knee arthroplasty	Synovectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome scores. e.g. knee society score (KSS)		one year
knee pain e.g. visual analogue score (VAS) score		immediate postoperative
Health related quality of life e.g. short form (SF12) scale		one year
Revision rate		one year
Reoperation rate		one year
Range of motion		immediate postoperative
Range of motion		6 month
Range of motion		One year

Secondary Outcomes

Measure	Description	Time Frame
Postoperative blood loss		immediate postoperative
Postoperative hemoglobin level	gram/dl	immediate postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

Inflammatory arthritis
Revision knee arthroplasty

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Saeed Younis, Dr.	Contact	201012370677		ahmed.s.younis@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed Saeed Younis, Dr.	Ain Shams University	Principal Investigator
Amr Amal Elsayed Amin, Dr.	Ain Shams University	Study Director
Wael Samir Osman, Professor

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Univrsity	Recruiting	Cairo		11566	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000074402	Synovectomy

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided