Back to resultsApproach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Primary Purpose
Arthropathy, Incision, Surgical, Obesity, Morbid
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Small curved incision with apex lateral
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy focused on measuring Total knee arthroplasty, obese
Eligibility Criteria
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
Sites / Locations
- Ahmed SaeedRecruiting
- Ahmed SaeedRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Total knee arthroplasty
Arm Description
Outcomes
Primary Outcome Measures
Functional outcomes
Knee society score
length of skin incision
lenght of skin incision in centimeters
operative time
Oprative time in minutes
Secondary Outcome Measures
revision rate
no. of patients requiring revision
wound complications
Any reported wound complications
wound infection
No of patients with wound infection
Range of motion
Range of knee flexion and extension in degrees
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05840705
Brief Title
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Official Title
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy, Incision, Surgical, Obesity, Morbid
Keywords
Total knee arthroplasty, obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total knee arthroplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Small curved incision with apex lateral
Intervention Description
Small curved incision with apex lateral
Primary Outcome Measure Information:
Title
Functional outcomes
Description
Knee society score
Time Frame
3 years
Title
length of skin incision
Description
lenght of skin incision in centimeters
Time Frame
7 years
Title
operative time
Description
Oprative time in minutes
Time Frame
7 years
Secondary Outcome Measure Information:
Title
revision rate
Description
no. of patients requiring revision
Time Frame
7 years
Title
wound complications
Description
Any reported wound complications
Time Frame
7 years
Title
wound infection
Description
No of patients with wound infection
Time Frame
7 years
Title
Range of motion
Description
Range of knee flexion and extension in degrees
Time Frame
7 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ahmed Saeed
City
Cairo
ZIP/Postal Code
11311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Saeed
Phone
01012370677
Email
ahmed.s.younis@med.asu.edu.eg
Facility Name
Ahmed Saeed
City
Cairo
ZIP/Postal Code
11311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Saeed
Phone
+201012370677
Email
ahmed.s.younis@med.asu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
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