Onlay Patellar Resurfacing TechniqueNCT03650426
Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty
A study testing Total knee with onlay patellar resurfacing technique and Total knee with inlay patellar resurfacing technique in people with Onlay Patellar Resurfacing Technique and Inlay Patellar Resurfacing Technique, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Onlay Patellar Resurfacing Technique, Inlay Patellar Resurfacing Technique, Patellar Resurfacing
- What is being tested?
- Total knee with onlay patellar resurfacing technique and Total knee with inlay patellar resurfacing technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteThailand
- Study dates
- 20 Feb 2018to 20 Feb 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 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
Who cannot join
- Valgus deformity
- History of inflammatory arthroplathy
- Previous fracture or open surgery on the same knee
- History of patellar instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique
- Conditions
- Onlay Patellar Resurfacing Technique, Inlay Patellar Resurfacing Technique, Patellar Resurfacing
- Being tested
- Total knee with onlay patellar resurfacing technique, Total knee with inlay patellar resurfacing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee with onlay patellar resurfacing techniqueProcedure or surgery
The patellar resurfacing technique that the patellar implant is embedded on the patellar bone.The patellar implant is placed on top of a flat tibial osteotomy or cut-surfaced bone
Total knee with inlay patellar resurfacing techniqueProcedure or surgery
The patellar resurfacing technique that the patellar implant is embedded in the patellar bone.The patellar implant is surrounded by a rim of cortical bone and supported by hardened, sclerotic bone
| Study group | Role | What they receive |
|---|---|---|
| Onlay patellar resurfacing technique | Active comparator | Not described Receives: Procedure: Total knee with onlay patellar resurfacing technique |
| Inlay patellar resurfacing technique | Experimental | Not described Receives: Procedure: Total knee with inlay patellar resurfacing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of post-operative anterior knee pain
Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome
Measured: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
range of motion of knee
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
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
Prevalence of patellar crepitus complication
Prevalence of patellar crepitus complication (present, absent)
Measured: Change from baseline patellar crepitus complication 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 posted28 Aug 2018
- Study start20 Feb 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onlay Patellar Resurfacing TechniqueStudies 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
- 235 participants (actual)
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, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650426
- Sponsor's protocol ID
- COA 017/2561
- Status last verified
- Jul 2018
- First submitted
- 27 Aug 2018
- Last updated
- 20 Apr 2021
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03650426
- Acronym / sponsor ID
- COA 017/2561
- Conditions
- Onlay Patellar Resurfacing Technique, Inlay Patellar Resurfacing Technique, Patellar Resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 28 Aug 2018 (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 posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique
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 |
|---|---|---|
| Onlay patellar resurfacing technique | Active comparator | Procedure: Total knee with onlay patellar resurfacing technique |
| Inlay patellar resurfacing technique | Experimental | Procedure: Total knee with inlay patellar resurfacing technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
Key exclusion criteria (4 listed)
- Valgus deformity
- History of inflammatory arthroplathy
- Previous fracture or open surgery on the same knee
- 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 |
|---|---|---|
| Total knee with onlay patellar resurfacing techniqueThe patellar resurfacing technique that the patellar implant is embedded on the patellar bone.The patellar implant is placed on top of a flat tibial osteotomy or cut-surfaced bone | Procedure or surgery | Onlay patellar resurfacing technique |
| Total knee with inlay patellar resurfacing techniqueThe patellar resurfacing technique that the patellar implant is embedded in the patellar bone.The patellar implant is surrounded by a rim of cortical bone and supported by hardened, sclerotic bone | Procedure or surgery | Inlay patellar resurfacing technique |
Primary outcome
Change of post-operative anterior knee pain
Time frame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome
range of motion of knee
Time frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
Knee Society and Knee Society function score (minimum 0, maximum 200)
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
Knee Society and Knee Society function score (minimum 0, maximum 200)
New patellar score
Time frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
New patellar score (minimum 0, maximum 30)
Oxford knee score
Time frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Oxford knee score (minimum 0, maximum 48)
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
Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)
Prevalence of patellar crepitus complication
Time frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
Prevalence of patellar crepitus complication (present, absent)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee with onlay patellar resurfacing technique and Total knee with inlay patellar resurfacing technique in people with Onlay Patellar Resurfacing Technique and Inlay Patellar Resurfacing Technique, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 20 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of post-operative anterior knee pain (time frame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery). The study lists 7 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 20 Apr 2021.