Total Knee ArthroplastyNCT03600922
Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty
A study testing the patella was resurfaced. in people with Total Knee Arthroplasty, run by Liaocheng People's Hospital.
Trial summary
The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- the patella was resurfaced.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Aug 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative OA
- 50-75 years
- All patients with OA were bilateral knee OA
Who cannot join
- previous patellectomy
- inflammatory arthritis
- patellar fracture
- patellar instability
- previous extensor mechanism procedures
- high tibial osteotomy,
Show all 9Show fewer
- severe valgus or varus deformity (> 20°), severe flexion contracture (> 30°)
- previous unicondylar knee replacement
- a history of septic arthritis or osteomyelitis.
About this study
Official title: A Prospective Randomized Clinical Study of Patellar Resurfacing and Non-resurfacing in One-stage Bilateral Total Knee Arthroplasty
The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.
Read the detailed description
Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.
- Conditions
- Total Knee Arthroplasty
- Being tested
- the patella was resurfaced.
- Keywords
- Osteoarthritis, Patellar resurfacing, Anterior knee pain
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the patella was resurfaced.Procedure or surgery
Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Procedure: the patella was resurfaced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Feller score
The Feller score consists four parts.Total score is 30 score (0-30) and the higher values represent a better outcome. The Feller score has points for Anterior knee pain (0 worst-15 best), quadriceps strength (1 worst -5 best) , ability to rise from chairand stability(0 worst-5 best )and stair-climbing(2 worst-5 best ). The scores from each item are summed to produce a total score
Measured: Baseline,1,2,3,4 and 5 years
Change From Baseline in visual analogue scale (VAS)
The Visual analogue scale (VAS)is ranging from 0 to 10 points, with 0 being no pain and 10 being maximum pain.The higher values represent a worse outcome.
Measured: Baseline,1,2,3,4 and 5 years
Change From Baseline in knee society score ( KSS)
The knee society score ( KSS) which consists of a 100-point scale for knee score and 100-point score for function score. The knee score has points for pain (0 worst -50 best ), range of motion (0 worst -25 best ) and stability (0 worst -25 best ). scores from each item are summed to produce a total score .The function score has points for walking ability (0 worst -50 best ) and stair climbing ability (0 worst -50 best ), scores from each item are summed to produce a total score.The knee score and the function score are recorded respectively.The higher values represent a better outcome.
Measured: Baseline,1,2,3,4 and 5 years
Change From Baseline in anteroposterior long weight-bearing X-ray
anteroposterior long weight-bearing X-ray
Measured: Baseline,1,2,3,4 and 5 years
Change From Baseline in MOS item short from health survey(SF-36)
The MOS item short from health survey(SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Baseline,1,2,3,4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600922
- Sponsor's protocol ID
- LCHOSPITAL-123456
- Status last verified
- Jul 2018
- First submitted
- 1 Jun 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ha C, Wang B, Li W, Sun K, Wang D, Li Q. Resurfacing versus not-resurfacing the patella in one-stage bilateral total knee arthroplasty: a prospective randomized clinical trial. Int Orthop. 2019 Nov;43(11):2519-2527. doi: 10.1007/s00264-019-04361-7. Epub 2019 Jun 21.
PubMed 31227852
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Study of Patellar Resurfacing and Non-resurfacing in One-stage Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03600922
- Acronym / sponsor ID
- LCHOSPITAL-123456
- Conditions
- Total Knee Arthroplasty
- Keywords
- Osteoarthritis, Patellar resurfacing, Anterior knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Jul 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 literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.
Detailed description
Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: the patella was resurfaced. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- degenerative OA
- 50-75 years
- All patients with OA were bilateral knee OA
Key exclusion criteria (9 listed)
- previous patellectomy
- inflammatory arthritis
- patellar fracture
- patellar instability
- previous extensor mechanism procedures
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 |
|---|---|---|
| the patella was resurfaced.Patellar resurfacing was undertaken using a cemented, inset domed component in TKA. | Procedure or surgery | Intervention group |
Primary outcome
Change From Baseline in the Feller score
Time frame: Baseline,1,2,3,4 and 5 years
The Feller score consists four parts.Total score is 30 score (0-30) and the higher values represent a better outcome. The Feller score has points for Anterior knee pain (0 worst-15 best), quadriceps strength (1 worst -5 best) , ability to rise from chairand stability(0 worst-5 best )and stair-climbing(2 worst-5 best ). The scores from each item are summed to produce a total score
Change From Baseline in visual analogue scale (VAS)
Time frame: Baseline,1,2,3,4 and 5 years
The Visual analogue scale (VAS)is ranging from 0 to 10 points, with 0 being no pain and 10 being maximum pain.The higher values represent a worse outcome.
Change From Baseline in knee society score ( KSS)
Time frame: Baseline,1,2,3,4 and 5 years
The knee society score ( KSS) which consists of a 100-point scale for knee score and 100-point score for function score. The knee score has points for pain (0 worst -50 best ), range of motion (0 worst -25 best ) and stability (0 worst -25 best ). scores from each item are summed to produce a total score .The function score has points for walking ability (0 worst -50 best ) and stair climbing ability (0 worst -50 best ), scores from each item are summed to produce a total score.The knee score and the function score are recorded respectively.The higher values represent a better outcome.
Change From Baseline in anteroposterior long weight-bearing X-ray
Time frame: Baseline,1,2,3,4 and 5 years
anteroposterior long weight-bearing X-ray
Change From Baseline in MOS item short from health survey(SF-36)
Time frame: Baseline,1,2,3,4 and 5 years
The MOS item short from health survey(SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
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 27 Jul 2018.
- Derived from this study: PubMed 31227852Ha C, Wang B, Li W, Sun K, Wang D, Li Q. Resurfacing versus not-resurfacing the patella in one-stage bilateral total knee arthroplasty: a prospective randomized clinical trial. Int Orthop. 2019 Nov;43(11):2519-2527. doi: 10.1007/s00264-019-04361-7. Epub 2019 Jun 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the patella was resurfaced. in people with Total Knee Arthroplasty, run by Liaocheng People's Hospital.
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 3 inclusion and 9 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 27 Jul 2018. 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?
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 From Baseline in the Feller score (time frame: Baseline,1,2,3,4 and 5 years). The study lists 5 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 NCT03600922, which also lists 1 linked publication.
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 27 Jul 2018.