Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

April 30, 2023 updated by: Ahmed Saeed Younis, Ain Shams University
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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

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

Description

Inclusion Criteria:

  • Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause

Exclusion Criteria:

  • candidates not meeting the inclusion criteria

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total knee arthroplasty
Procedure: Small curved incision with apex lateral
Small curved incision with apex lateral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes
Time Frame: 3 years
Knee society score
3 years
length of skin incision
Time Frame: 7 years
lenght of skin incision in centimeters
7 years
operative time
Time Frame: 7 years
Oprative time in minutes
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
revision rate
Time Frame: 7 years
no. of patients requiring revision
7 years
wound complications
Time Frame: 7 years
Any reported wound complications
7 years
wound infection
Time Frame: 7 years
No of patients with wound infection
7 years
Range of motion
Time Frame: 7 years
Range of knee flexion and extension in degrees
7 years

Collaborators and Investigators

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

Sponsor

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 (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

June 8, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54321askay

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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