Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05840705
Collaborator
(none)
100
2
1
65.2
50
0.8
Study Details
Study Description
Brief Summary
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Actual Study Start Date
:
Jan 1, 2018
Actual Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Jun 8, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Total knee arthroplasty
|
Procedure: Small curved incision with apex lateral
Small curved incision with apex lateral
|
Outcome Measures
Primary Outcome Measures
- Functional outcomes [3 years]
Knee society score
- length of skin incision [7 years]
lenght of skin incision in centimeters
- operative time [7 years]
Oprative time in minutes
Secondary Outcome Measures
- revision rate [7 years]
no. of patients requiring revision
- wound complications [7 years]
Any reported wound complications
- wound infection [7 years]
No of patients with wound infection
- Range of motion [7 years]
Range of knee flexion and extension in degrees
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahmed Saeed | Cairo | Egypt | 11311 | |
| 2 | Ahmed Saeed | Cairo | Egypt | 11311 |
Sponsors and Collaborators
- Ain Shams University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed Saeed Younis,
Lecturer of orthopaedics,
Ain Shams University
ClinicalTrials.gov Identifier:
NCT05840705
Other Study ID Numbers:
- 54321askay
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
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
Keywords provided by Ahmed Saeed Younis,
Lecturer of orthopaedics,
Ain Shams University
Additional relevant MeSH terms: