Approach Modification for Total Knee Arthroplasty in Morb... | NCT05840705

Studies
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

NCT05840705

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

May 3, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Arthropathy
Incision, Surgical
Obesity, Morbid

Interventions

Small curved incision with apex lateral

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jun 8, 2023Estimated

First Submitted Date

Jan 1, 2023

First Submission Date that Met QC Criteria

Apr 30, 2023

First Posted Date

May 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2023

Last Update Posted Date

May 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total knee arthroplasty	Experimental		Procedure: Small curved incision with apex lateral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Small curved incision with apex lateral	Procedure	Small curved incision with apex lateral	Total knee arthroplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
revision rate	no. of patients requiring revision	7 years
wound complications	Any reported wound complications	7 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Saeed	Recruiting	Cairo		11311	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007592	Joint Diseases
D000072836	Surgical Wound
D009767	Obesity, Morbid
D009765	Obesity

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries
D050177	Overweight
D044343	Overnutrition

Browse Leaves

Not provided

Browse Branches

Not provided