ArthropathyNCT05840705
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
A study testing Small curved incision with apex lateral in people with Arthropathy and Incision, Surgical, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy, Incision, Surgical, Obesity, Morbid
- What is being tested?
- Small curved incision with apex lateral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2018to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause
Who cannot join
- candidates not meeting the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ahmed Saeed
Cairo, 11311
Ahmed Saeed, 01012370677, ahmed.s.younis@med.asu.edu.eg
- Recruiting
Ahmed Saeed
Cairo, 11311
Ahmed Saeed, +201012370677, ahmed.s.younis@med.asu.edu.eg
About this study
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations
- Conditions
- Arthropathy, Incision, Surgical, Obesity, Morbid
- Being tested
- Small curved incision with apex lateral
- Keywords
- Total knee arthroplasty, obese
- Medical subject headings
- Joint Diseases, Surgical Wound, Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small curved incision with apex lateralProcedure or surgery
Small curved incision with apex lateral
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Experimental | Not described Receives: Procedure: Small curved incision with apex lateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes
Knee society score
Measured: 3 years
length of skin incision
lenght of skin incision in centimeters
Measured: 7 years
operative time
Oprative time in minutes
Measured: 7 years
Secondary outcomes (4)
revision rate
no. of patients requiring revision
Measured: 7 years
wound complications
Any reported wound complications
Measured: 7 years
wound infection
No of patients with wound infection
Measured: 7 years
Range of motion
Range of knee flexion and extension in degrees
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion8 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saeed Younis, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840705
- Sponsor's protocol ID
- 54321askay
- Status last verified
- Apr 2023
- First submitted
- 1 Jan 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT05840705
- Acronym / sponsor ID
- 54321askay
- Conditions
- Arthropathy, Incision, Surgical, Obesity, Morbid
- Keywords
- Total knee arthroplasty, obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 8 Jun 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | Experimental | Procedure: Small curved incision with apex lateral |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause
Key exclusion criteria (1 listed)
- candidates not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small curved incision with apex lateralSmall curved incision with apex lateral | Procedure or surgery | Total knee arthroplasty |
Primary outcome
Functional outcomes
Time frame: 3 years
Knee society score
length of skin incision
Time frame: 7 years
lenght of skin incision in centimeters
operative time
Time frame: 7 years
Oprative time in minutes
4 secondary outcomes
revision rate
Time frame: 7 years
wound complications
Time frame: 7 years
wound infection
Time frame: 7 years
Range of motion
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small curved incision with apex lateral in people with Arthropathy and Incision, Surgical, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.