Synovectomy in Primary Total Knee Arthrplasty

December 14, 2018 updated by: Ahmed Saeed Younis, Ain Shams University

Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Recruiting
        • Ain Shams Univrsity
        • Contact:
          • Ain Shams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with primary osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

  • Inflammatory arthritis
  • Revision knee arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synovectomy
Other: Synovectomy
Removal of the synovium during total knee arthroplasty
No Intervention: No synovectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative blood loss
Time Frame: immediate postoperative
immediate postoperative
Postoperative hemoglobin level
Time Frame: immediate postoperative
gram/dl
immediate postoperative
Infection rate
Time Frame: in first three month
in first three month
Wound complications
Time Frame: in first 3 months
in first 3 months
Number of patients requiring transfusion
Time Frame: immediate postoperative
immediate postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed Saeed Younis, Dr., Ain Shams University
  • Study Director: Amr Amal Elsayed Amin, Dr., Ain Shams University
  • Study Chair: Wael Samir Osman, professor, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 12370677

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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