Patellar CrepitusNCT02997579
Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients
A study testing patellar resurfacing in people with Patellar Crepitus and Vibroacoustic Signal, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patellar Crepitus, Vibroacoustic Signal
- What is being tested?
- patellar resurfacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2016to Jan 2019
- 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 cannot join
- rheumatoid arthritis
- morbid obesity
- severe patellofemoral joint destruction
- patella maltracking
- patellofemoral incongruent
- inflammatory arthritis
- refuse to participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.
- Conditions
- Patellar Crepitus, Vibroacoustic Signal
- Being tested
- patellar resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patellar resurfacingProcedure or surgery
patellar component insert with cement
| Study group | Role | What they receive |
|---|---|---|
| patellar resurfacing | Experimental | patellar resurfacing TKA Receives: Procedure: patellar resurfacing |
| patellar non-resurfacing | No intervention | patellar non-resurfacing TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of patellar crepitus
patellar crepitus investigate by physical examination
Measured: pre-op, 3, 6 month
change of mean of vibroacoustic signal
Measured: pre-op, 3, 6 month
Secondary outcomes (1)
Number of patellar crepitus related to mean of vibroacoustic signal
study the association between patellar crepitus and vibroacoustic signal, patellar crepitus investigate by physical examination and mean of vibroacoustic signal assessed by an acceleration sensor
Measured: pre-op, 3, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion15 Dec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellar CrepitusStudies 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
- 102 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
- NCT02997579
- Sponsor's protocol ID
- COA113/2559
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2016
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Baczkowicz D, Majorczyk E. Joint motion quality in vibroacoustic signal analysis for patients with patellofemoral joint disorders. BMC Musculoskelet Disord. 2014 Dec 12;15:426. doi: 10.1186/1471-2474-15-426.
PubMed 25496721Tanaka N, Hoshiyama M. Vibroarthrography in patients with knee arthropathy. J Back Musculoskelet Rehabil. 2012;25(2):117-22. doi: 10.3233/BMR-2012-0319.
PubMed 22684203
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT02997579
- Acronym / sponsor ID
- COA113/2559
- Conditions
- Patellar Crepitus, Vibroacoustic Signal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patellar resurfacing | Experimental | Procedure: patellar resurfacingpatellar resurfacing TKA |
| patellar non-resurfacing | No intervention | –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
Key exclusion criteria (7 listed)
- rheumatoid arthritis
- morbid obesity
- severe patellofemoral joint destruction
- patella maltracking
- patellofemoral incongruent
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 |
|---|---|---|
| patellar resurfacingpatellar component insert with cement | Procedure or surgery | patellar resurfacing |
Primary outcome
change of patellar crepitus
Time frame: pre-op, 3, 6 month
patellar crepitus investigate by physical examination
change of mean of vibroacoustic signal
Time frame: pre-op, 3, 6 month
1 secondary outcome
Number of patellar crepitus related to mean of vibroacoustic signal
Time frame: pre-op, 3, 6 month
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 7 Jan 2019.
- Background: PubMed 25496721Baczkowicz D, Majorczyk E. Joint motion quality in vibroacoustic signal analysis for patients with patellofemoral joint disorders. BMC Musculoskelet Disord. 2014 Dec 12;15:426. doi: 10.1186/1471-2474-15-426.
- Background: PubMed 22684203Tanaka N, Hoshiyama M. Vibroarthrography in patients with knee arthropathy. J Back Musculoskelet Rehabil. 2012;25(2):117-22. doi: 10.3233/BMR-2012-0319.
- 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 patellar resurfacing in people with Patellar Crepitus and Vibroacoustic Signal, 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 7 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 7 Jan 2019. 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 patellar crepitus (time frame: pre-op, 3, 6 month). 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?
On the ClinicalTrials.gov record for NCT02997579, which also lists 2 linked publications.
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 7 Jan 2019.