NCT05840705

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

January 1, 2023

Last Update Submit

April 30, 2023

Conditions

ArthropathyIncision, SurgicalObesity, Morbid

Keywords

Total knee arthroplastyobese

Outcome Measures

Primary Outcomes (3)

  • 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 (4)

  • revision rate

    7 years

  • wound complications

    7 years

  • wound infection

    7 years

  • Range of motion

    7 years

Study Arms (1)

Total knee arthroplasty

EXPERIMENTAL
Procedure: Small curved incision with apex lateral

Interventions

Small curved incision with apex lateralPROCEDURE

Small curved incision with apex lateral

Total knee arthroplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Saeed

Cairo, 11311, Egypt

RECRUITING

Ahmed Saeed

Cairo, 11311, Egypt

RECRUITING

MeSH Terms

Conditions

Joint DiseasesSurgical WoundObesity, MorbidObesity

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesWounds and InjuriesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of orthopaedics

Study Record Dates

First Submitted

January 1, 2023

First Posted

May 3, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

June 8, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

EG(2)