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Synovectomy in Primary Total Knee Arthrplasty

NCT ID: NCT03778463

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Arthroplasty, Replacement, Knee Synovectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Synovectomy

Group Type EXPERIMENTAL

Synovectomy

Intervention Type OTHER

Removal of the synovium during total knee arthroplasty

No synovectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Synovectomy

Removal of the synovium during total knee arthroplasty

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria

* Inflammatory arthritis
* Revision knee arthroplasty
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Saeed Younis

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Saeed Younis, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Amr Amal Elsayed Amin, Dr.

Role: STUDY_DIRECTOR

Ain Shams University

Wael Samir Osman, Professor

Role: STUDY_CHAIR

Ain Shams University

Locations

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Ain Shams Univrsity

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Saeed Younis, Dr.

Role: CONTACT

Phone: 201012370677

Email: [email protected]

Facility Contacts

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Ain Shams

Role: primary

Other Identifiers

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12370677

Identifier Type: -

Identifier Source: org_study_id