Patellar DenervationNCT03389880
Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing
A study testing Total knee arthroplasty and Patellar denervation in people with Patellar Denervation and Non-patellar Denervation, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patellar Denervation, Non-patellar Denervation, Patellar Resurfacing
- What is being tested?
- Total knee arthroplasty and Patellar denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteThailand
- Study dates
- 21 Dec 2017to 20 Aug 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: Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial
The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing
- Being tested
- Total knee arthroplasty, Patellar denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Patellar denervationProcedure or surgery
circumpatellar electrocautery with monopolar coagulation diathermy
| Study group | Role | What they receive |
|---|---|---|
| Patellar denervation | Active comparator | Not described Receives: Procedure: Total knee arthroplasty; Procedure: Patellar denervation |
| Non-patellar denervation | Experimental | Not described Receives: Procedure: Total knee arthroplasty |
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
Secondary outcomes (8)
range of motion of knee
degree of motion of the knee after surgery
Measured: Change from baseline range of motion of knee 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 (Bartlett score)
New patellar score or Bartlett 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
patellar shift index
The estimation of patellar position relative to the trochear
Measured: Change from baseline 3 months, 6 months, and 12 months after surgery
prevalence of anterior knee pain
Percent of anterior knee pain
Measured: Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
activity of daily living
activity of daily living score (minimum 0, maximum 20)
Measured: Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
post-operative complication
Number and type of post-operative complication
Measured: Number and type of post-operative complication 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 posted4 Jan 2018
- Study start21 Dec 2017
- Primary completion15 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DenervationStudies 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
- 241 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
- NCT03389880
- Sponsor's protocol ID
- COA 147/2560
- Status last verified
- Nov 2020
- First submitted
- 20 Dec 2017
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03389880
- Acronym / sponsor ID
- COA 147/2560
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 4 Jan 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 the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing
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 |
|---|---|---|
| Patellar denervation | Active comparator | Procedure: Total knee arthroplasty, Procedure: Patellar denervation |
| Non-patellar denervation | Experimental | Procedure: Total knee arthroplasty |
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 arthroplastyA surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses) | Procedure or surgery | Non-patellar denervation, Patellar denervation |
| Patellar denervationcircumpatellar electrocautery with monopolar coagulation diathermy | Procedure or surgery | Patellar denervation |
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
8 secondary outcomes
range of motion of knee
Time frame: Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery
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 (Bartlett 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
patellar shift index
Time frame: Change from baseline 3 months, 6 months, and 12 months after surgery
prevalence of anterior knee pain
Time frame: Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
activity of daily living
Time frame: Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
post-operative complication
Time frame: Number and type of post-operative complication at 3 months, 6 months, and 12 months after surgery
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 23 Nov 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.
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 arthroplasty and Patellar denervation in people with Patellar Denervation and Non-patellar Denervation, 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 23 Nov 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?
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). 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 23 Nov 2020.