Removal of Fibrosynovial TissueNCT04429997
Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella
A study testing Removal of fibrosynovial tissue and Non-removal of fibrosynovial tissue in people with Removal of Fibrosynovial Tissue and Non-removal of Fibrosynovial Tissue, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Removal of Fibrosynovial Tissue, Non-removal of Fibrosynovial Tissue, Patellar Non-resurfacing
- What is being tested?
- Removal of fibrosynovial tissue and Non-removal of fibrosynovial tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jun 2020to 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
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: Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar
The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.
- Conditions
- Removal of Fibrosynovial Tissue, Non-removal of Fibrosynovial Tissue, Patellar Non-resurfacing
- Being tested
- Removal of fibrosynovial tissue, Non-removal of fibrosynovial tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of fibrosynovial tissueProcedure or surgery
Remove of fibrosynovial tissue at the superior border of patella
Non-removal of fibrosynovial tissueProcedure or surgery
Do not remove of fibrosynovial tissue at the superior border of patella
| Study group | Role | What they receive |
|---|---|---|
| Removal of fibrosynovial tissue | Experimental | Removal of fibrosynovial tissue in patellar non-resurfacing TKA Receives: Procedure: Removal of fibrosynovial tissue |
| Non-removal of fibrosynovial tissue | Experimental | Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA Receives: Procedure: Non-removal of fibrosynovial tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patellar crepitus complication
Incidence of patellar crepitus complication (present, absent)
Measured: Change from baseline patellar crepitus complication 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start10 Jun 2020
- Primary completionJul 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 Removal of Fibrosynovial TissueStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 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
- NCT04429997
- Sponsor's protocol ID
- COA 057/2563
- Status last verified
- Aug 2021
- First submitted
- 10 Jun 2020
- Last updated
- 31 Aug 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar
- ClinicalTrials.gov ID
- NCT04429997
- Acronym / sponsor ID
- COA 057/2563
- Conditions
- Removal of Fibrosynovial Tissue, Non-removal of Fibrosynovial Tissue, Patellar Non-resurfacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Jun 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.
The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removal of fibrosynovial tissue | Experimental | Procedure: Removal of fibrosynovial tissueRemoval of fibrosynovial tissue in patellar non-resurfacing TKA |
| Non-removal of fibrosynovial tissue | Experimental | Procedure: Non-removal of fibrosynovial tissueNon-removal of fibrosynovial tissue in patellar non-resurfacing TKA |
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 |
|---|---|---|
| Removal of fibrosynovial tissueRemove of fibrosynovial tissue at the superior border of patella | Procedure or surgery | Removal of fibrosynovial tissue |
| Non-removal of fibrosynovial tissueDo not remove of fibrosynovial tissue at the superior border of patella | Procedure or surgery | Non-removal of fibrosynovial tissue |
Primary outcome
Incidence of patellar crepitus complication
Time frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
Incidence of patellar crepitus complication (present, absent)
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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 Removal of fibrosynovial tissue and Non-removal of fibrosynovial tissue in people with Removal of Fibrosynovial Tissue and Non-removal of Fibrosynovial Tissue, 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: status not confirmed, as of the sponsor's last update on 31 Aug 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?
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?
Incidence of patellar crepitus complication (time frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery). 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 31 Aug 2021.