Knee OsteoarthritisNCT04637490
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
A study testing patellar component in people with Knee Osteoarthritis, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- patellar component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Nov 2018
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 55 to 80 years
- unilateral primary osteoarthritis
Who cannot join
- bilateral osteoarthritis
- inflammatory arthritis
- post-traumatic osteoarthritis
- previous knee surgery
- neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Teaching and Research Hospital
Ankara, 06010
About this study
For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.
Read the detailed description
Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.
- Conditions
- Knee Osteoarthritis
- Being tested
- patellar component
- Keywords
- patellar resurfacing, isokinetic testing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patellar componentDevice
patellar resurfacing
| Study group | Role | What they receive |
|---|---|---|
| patellar resurfacing | Experimental | patellar resurfacing in TKA Receives: Device: patellar component |
| non-resurfacing | No intervention | non-resurfacing TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
isokinetic test
isokinetic test during extension and flexion of the knee
Measured: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary outcomes (1)
Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
Knee Society Score (KSS)
Measured: Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jun 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Deniz CANKAYA, Gulhane Training and Research Hospital
- Investigators
- Deniz CANKAYA, Assoc.Professor, Principal investigator, Gulhane Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637490
- Sponsor's protocol ID
- E-17-1414
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
- ClinicalTrials.gov ID
- NCT04637490
- Acronym / sponsor ID
- E-17-1414
- Conditions
- Knee Osteoarthritis
- Keywords
- patellar resurfacing, isokinetic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Nov 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.
For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.
Detailed description
Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patellar resurfacing | Experimental | Device: patellar componentpatellar resurfacing in TKA |
| non-resurfacing | No intervention | –non-resurfacing TKA |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 55 to 80 years
- unilateral primary osteoarthritis
Key exclusion criteria (5 listed)
- bilateral osteoarthritis
- inflammatory arthritis
- post-traumatic osteoarthritis
- previous knee surgery
- neuromuscular diseases
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 componentpatellar resurfacing | Device | patellar resurfacing |
Primary outcome
isokinetic test
Time frame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
isokinetic test during extension and flexion of the knee
1 secondary outcome
Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
Time frame: Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results
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 19 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Deniz CANKAYA, Assoc.Professor principal investigator
Gulhane Teaching and Research Hospital
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 component in people with Knee Osteoarthritis, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 19 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 Turkey (Türkiye). 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?
isokinetic test (time frame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results). 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 19 Nov 2020.