Complete ContactNCT05349461
Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty
A study testing Complete patellofemoral articular contact and Incomplete patellofemoral articular contact in people with Complete Contact and Incomplete Contact, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complete Contact, Incomplete Contact
- What is being tested?
- Complete patellofemoral articular contact and Incomplete patellofemoral articular contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 20 Apr 2021to Dec 2022
- 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
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- Age 50-80 year
Who cannot join
- Revision surgery
- Bilateral total knee arthroplasty
- History of patellar fracture
- History of patellar chondromalacia
- History of Patellar instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts
- Conditions
- Complete Contact, Incomplete Contact
- Being tested
- Complete patellofemoral articular contact, Incomplete patellofemoral articular contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete patellofemoral articular contactProcedure or surgery
The patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.
Incomplete patellofemoral articular contactProcedure or surgery
The patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.
| Study group | Role | What they receive |
|---|---|---|
| Complete contact | Active comparator | Not described Receives: Procedure: Complete patellofemoral articular contact |
| Incomplete contact | Active comparator | Not described Receives: Procedure: Incomplete patellofemoral articular contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee range of motion (ROM)
Goniometer measure range of motion (minimum 0, maximum 145)
Measured: Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery
Knee flexion
Goniometer measure knee flexion (minimum 135, maximum 145)
Measured: Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery
Knee extension
Goniometer measure knee extension (minimum -10, maximum 0)
Measured: Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery
Secondary outcomes (4)
Knee Society and Knee Society function score
Knee Society and Knee Society function score (minimum 0, maximum 200)
Measured: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
New patellar score
New patellar score (minimum 0, maximum 30)
Measured: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Oxford knee score (minimum 0, maximum 48)
Measured: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Prevalence of anterior knee pain ,AKP
Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)
Measured: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 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 Apr 2022
- Study start20 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete ContactStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, satitthh@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349461
- Sponsor's protocol ID
- COA 010/2563
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2022
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05349461
- Acronym / sponsor ID
- COA 010/2563
- Conditions
- Complete Contact, Incomplete Contact
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Apr 2022 (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 purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete contact | Active comparator | Procedure: Complete patellofemoral articular contact |
| Incomplete contact | Active comparator | Procedure: Incomplete patellofemoral articular contact |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- Age 50-80 year
Key exclusion criteria (5 listed)
- Revision surgery
- Bilateral total knee arthroplasty
- History of patellar fracture
- History of patellar chondromalacia
- History of Patellar instability
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 |
|---|---|---|
| Complete patellofemoral articular contactThe patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test. | Procedure or surgery | Complete contact |
| Incomplete patellofemoral articular contactThe patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test. | Procedure or surgery | Incomplete contact |
Primary outcome
Knee range of motion (ROM)
Time frame: Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery
Goniometer measure range of motion (minimum 0, maximum 145)
Knee flexion
Time frame: Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery
Goniometer measure knee flexion (minimum 135, maximum 145)
Knee extension
Time frame: Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery
Goniometer measure knee extension (minimum -10, maximum 0)
4 secondary outcomes
Knee Society and Knee Society function score
Time frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
New patellar score
Time frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Time frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Prevalence of anterior knee pain ,AKP
Time frame: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 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 Apr 2022.
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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.
Satit Thiengwittayaporn, M.D. principal investigator
satitthh@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete patellofemoral articular contact and Incomplete patellofemoral articular contact in people with Complete Contact and Incomplete Contact, run by Navamindradhiraj 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 2 inclusion and 5 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 Apr 2022. 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?
Knee range of motion (ROM) (time frame: Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery). 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 27 Apr 2022.