Skin Numbness and Kneeling AbilityNCT04240847
Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA
A study testing Skin incision in people with Skin Numbness and Kneeling Ability, run by Thammasat University at 1 site in Thailand.
Trial summary
This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Skin Numbness and Kneeling Ability
- What is being tested?
- Skin incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2018to 30 Sep 2020
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient undergoing simultaneous bilateral TKA
- Normal skin sensation on both knees
- Informed consent
- Good cognitive function
Who cannot join
- Previous surgical wound around the knee
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066
About this study
Official title: Comparison of Skin Numbness and Kneeling Ability Between Midline Skin Incision Medial to Tibial Tubercle With Lateral to Tibial Tubercle Skin Incision in Simultaneous Bilateral Total Knee Arthroplasty
This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA
- Conditions
- Skin Numbness and Kneeling Ability
- Being tested
- Skin incision
- Keywords
- skin incision, numbness, kneeling, total knee arthroplasty
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin incisionProcedure or surgery
Skin incision on medial or lateral to tibial tubercle
| Study group | Role | What they receive |
|---|---|---|
| Midline incision | Active comparator | Skin incision at the midline, 1 cm medial to tibial tubercle Receives: Procedure: Skin incision |
| Lateral incision | Experimental | Skin incision at 1 cm lateral to tibial tubercle Receives: Procedure: Skin incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin numbness
area of skin numbness
Measured: 6 weeks, 3, 6 , 9, 12 months after surgery
Kneeling ability
Ability to kneel at 90 and 110 degrees on hard, firm and soft surface
Measured: 6 weeks, 3, 6 , 9, 12 months after surgery
Secondary outcomes (4)
Functional outcome
Modified WOMAC, Joint forgotten score
Measured: 6 weeks, 3, 6 , 9, 12 months after surgery
Knee range of motion
flexion and extension angle of knee by goniometer
Measured: 6 weeks, 3, 6 , 9, 12 months after surgery
Incision length
Skin incision length at 90 degrees knee flexion
Measured: 3 months
Complication
chronic eczema at surgical wound
Measured: 6 weeks, 3, 6 , 9, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Sep 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Numbness and Kneeling AbilityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240847
- Sponsor's protocol ID
- OrthoTU10
- Status last verified
- Jan 2020
- First submitted
- 11 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Numbness and Kneeling Ability Between Midline Skin Incision Medial to Tibial Tubercle With Lateral to Tibial Tubercle Skin Incision in Simultaneous Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04240847
- Acronym / sponsor ID
- OrthoTU10
- Conditions
- Skin Numbness and Kneeling Ability
- Keywords
- skin incision, numbness, kneeling, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 27 Jan 2020 (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.
This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline incision | Active comparator | Procedure: Skin incisionSkin incision at the midline, 1 cm medial to tibial tubercle |
| Lateral incision | Experimental | Procedure: Skin incisionSkin incision at 1 cm lateral to tibial tubercle |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient undergoing simultaneous bilateral TKA
- Normal skin sensation on both knees
- Informed consent
- Good cognitive function
Key exclusion criteria (2 listed)
- Previous surgical wound around the knee
- Peripheral vascular disease
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 |
|---|---|---|
| Skin incisionSkin incision on medial or lateral to tibial tubercle | Procedure or surgery | Lateral incision, Midline incision |
Primary outcome
Skin numbness
Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery
area of skin numbness
Kneeling ability
Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Ability to kneel at 90 and 110 degrees on hard, firm and soft surface
4 secondary outcomes
Functional outcome
Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Knee range of motion
Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Incision length
Time frame: 3 months
Complication
Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin incision in people with Skin Numbness and Kneeling Ability, run by Thammasat University at 1 site in Thailand.
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 4 inclusion and 2 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin numbness (time frame: 6 weeks, 3, 6 , 9, 12 months after surgery). The study lists 2 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 27 Jan 2020.