Osteoarthritis, Patella ResurfacingNCT02683460
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
A study testing Patella resurfacing and Patella retention in people with Osteoarthritis, Patella Resurfacing, run by The Catholic University of Korea.
Trial summary
This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Patella Resurfacing
- What is being tested?
- Patella resurfacing and Patella retention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for total knee arthroplasty
- Having medicare insurance
Who cannot join
- Patients who are not able to cooperate
- Serious deformity (not suitable for a standard TKA prosthesis)
- Patellar thickness less than 18 mm
- Prior operation involving the extensor mechanism
- Rheumatoid arthritis
- Severe medical disability limiting the ability to walk
- Revision surgery
- Knees with predominantly patellofemoral arthrosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.
This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
Read the detailed description
The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.
- Conditions
- Osteoarthritis, Patella Resurfacing
- Being tested
- Patella resurfacing, Patella retention
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patella resurfacingProcedure or surgery
Patella retentionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patella resurfacing group | Experimental | Procedure: Patellar component Resurfacing with onlay technique Receives: Procedure: Patella resurfacing |
| patella retention | Active comparator | Procedure: patellar retention Trimming of osteophytes when appropriate Receives: Procedure: Patella retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
Measured: Change from preoperative score to postoperative 2 years
Knee Society score
Measured: Change from preoperative score to postoperative 2 years
Secondary outcomes (2)
Feller's score
Measured: Change from preoperative score to postoperative 2 years
Patients satisfaction using Visual Analog Score for pain
Measured: Change from preoperative score to postoperative 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, Patella ResurfacingStudies 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, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, the Catholic Univerisity of Korea Seoul St Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683460
- Sponsor's protocol ID
- Patella resurfacing
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT02683460
- Acronym / sponsor ID
- Patella resurfacing
- Conditions
- Osteoarthritis, Patella Resurfacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 17 Feb 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.
This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.
This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
Detailed description
The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patella resurfacing group | Experimental | Procedure: Patella resurfacingProcedure: Patellar component Resurfacing with onlay technique |
| patella retention | Active comparator | Procedure: Patella retentionProcedure: patellar retention Trimming of osteophytes when appropriate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients for total knee arthroplasty
- Having medicare insurance
Key exclusion criteria (8 listed)
- Patients who are not able to cooperate
- Serious deformity (not suitable for a standard TKA prosthesis)
- Patellar thickness less than 18 mm
- Prior operation involving the extensor mechanism
- Rheumatoid arthritis
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 |
|---|---|---|
| Patella resurfacing | Procedure or surgery | patella resurfacing group |
| Patella retention | Procedure or surgery | patella retention |
Primary outcome
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
Time frame: Change from preoperative score to postoperative 2 years
Knee Society score
Time frame: Change from preoperative score to postoperative 2 years
2 secondary outcomes
Feller's score
Time frame: Change from preoperative score to postoperative 2 years
Patients satisfaction using Visual Analog Score for pain
Time frame: Change from preoperative score to postoperative 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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.
Yong In, MD, PhD study chair
the Catholic Univerisity of Korea Seoul St Mary's hospital
Questions about this trial
What is this clinical trial studying?
A study testing Patella resurfacing and Patella retention in people with Osteoarthritis, Patella Resurfacing, run by The Catholic University of Korea.
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 8 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (time frame: Change from preoperative score to postoperative 2 years). 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?
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 17 Feb 2016.