Osteo Arthritis KneeNCT05045651
Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
A study testing Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA in people with Osteo Arthritis Knee and Knee Pain Chronic, run by Thammasat University.
Trial summary
Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Osteo Arthritis Knee, Knee Pain Chronic
- What is being tested?
- Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 1 Dec 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aymptomatic knee OA with
- varus deformity < 30 degrees
- range of motion > 90 degrees
- flexion contracture < 20 degrees
- recurvatum < 20 degrees
Who cannot join
- gout
- postraumatic arthritis
- osteonecrosis of knee
- inflammatory joint disease
About this study
Official title: The Incidence of Anterior Knee Pain Between Unisex Knee Prosthesis and Gender Specific Knee Prosthesis Following Minimally Invasive Surgery Total Knee Arthroplasty: A Randomized Controlled Trial
Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking
Read the detailed description
Background:The anterior knee pain (AKP) is one of major problem of TKA. The incidence of anterior knee after TKA was 4% to 49%. The cause of AKP after TKA from surgical technique errors including joint line elevation, instability, malalignment of prosthesis, and maltracking of patella. However, AKP still has presented even high volume surgeon that prosthesis had good alignment and good stability, one of the risk factor is female. Due to female has higher Q-angle, greater anteroposterior (AP)/mediolateral(ML) ratio, smaller anterior condyle, and trochlea has higher degree of valgus angle than male. Therefore, female should has AKP even surgery with good surgical technique. The gender specific knee prosthesis was design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. For these reasons, the gender specific knee prosthesis should reduce AKP and improve patellar tracking in female. And there is no study to compare AKP and patellar tracking between Unisex knee prosthesis and gender specific knee prosthesis following minimally invasive surgery (MIS) TKA.
Investigators asked whether AKP and patellar tracking differ between unisex knee prosthesis and gender specific knee prosthesis following MIS TKA with patellar resurfacing.
Methods:The participants were randomized into 2 groups (Gp) with computer program to make a list of random numbers of participant. Gp1 was gender specific knee prosthesis; consisted of 40 participants (40 knees) and Gp2 was unisex knee prosthesis; consisted of 40 participants (40 knees). The sample size was calculate base on anterior knee pain after TKA with a risk difference of 27% (3% versus 20%) (1,3). The 40 participants from each group would have 90% power at the 5% significant level.
Patrticipants were follow up at 2 wks, 6 wks, 3 mo, 6mo, 1 year and 2 years. At each follow up, the % anterior knee pain, VAS for anterior knee pain were record. The knee society score also was recorded and compared between two group.
All participants were operated with same surgeon and same instrumentation.
- Conditions
- Osteo Arthritis Knee, Knee Pain Chronic
- Being tested
- Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
- Keywords
- anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USAProcedure or surgery
gender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male.
| Study group | Role | What they receive |
|---|---|---|
| patient specific knee prosthesis | Experimental | TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA Receives: Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA |
| Unisex knee prosthesis | Experimental | TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA Receives: Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior knee pain
Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
Measured: 4 years
patellar tracking
patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking
Measured: 4 years
Secondary outcomes (1)
clinical outcome score
knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Aug 2014
- Primary completion1 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
- Investigators
- Boonchana Pongcharoen, MD, Principal investigator, faculty of medicine, Thammasat university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045651
- Sponsor's protocol ID
- MTU-EC-OT-1-005/55
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Anterior Knee Pain Between Unisex Knee Prosthesis and Gender Specific Knee Prosthesis Following Minimally Invasive Surgery Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05045651
- Acronym / sponsor ID
- MTU-EC-OT-1-005/55
- Conditions
- Osteo Arthritis Knee, Knee Pain Chronic
- Keywords
- anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 16 Sep 2021 (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.
Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking
Detailed description
Background:The anterior knee pain (AKP) is one of major problem of TKA. The incidence of anterior knee after TKA was 4% to 49%. The cause of AKP after TKA from surgical technique errors including joint line elevation, instability, malalignment of prosthesis, and maltracking of patella. However, AKP still has presented even high volume surgeon that prosthesis had good alignment and good stability, one of the risk factor is female. Due to female has higher Q-angle, greater anteroposterior (AP)/mediolateral(ML) ratio, smaller anterior condyle, and trochlea has higher degree of valgus angle than male. Therefore, female should has AKP even surgery with good surgical technique. The gender specific knee prosthesis was design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. For these reasons, the gender specific knee prosthesis should reduce AKP and improve patellar tracking in female. And there is no study to compare AKP and patellar tracking between Unisex knee prosthesis and gender specific knee prosthesis following minimally invasive surgery (MIS) TKA.
Investigators asked whether AKP and patellar tracking differ between unisex knee prosthesis and gender specific knee prosthesis following MIS TKA with patellar resurfacing.
Methods:The participants were randomized into 2 groups (Gp) with computer program to make a list of random numbers of participant. Gp1 was gender specific knee prosthesis; consisted of 40 participants (40 knees) and Gp2 was unisex knee prosthesis; consisted of 40 participants (40 knees). The sample size was calculate base on anterior knee pain after TKA with a risk difference of 27% (3% versus 20%) (1,3). The 40 participants from each group would have 90% power at the 5% significant level.
Patrticipants were follow up at 2 wks, 6 wks, 3 mo, 6mo, 1 year and 2 years. At each follow up, the % anterior knee pain, VAS for anterior knee pain were record. The knee society score also was recorded and compared between two group.
All participants were operated with same surgeon and same instrumentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient specific knee prosthesis | Experimental | Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USATKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA |
| Unisex knee prosthesis | Experimental | Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USATKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aymptomatic knee OA with
- varus deformity < 30 degrees
- range of motion > 90 degrees
- flexion contracture < 20 degrees
- recurvatum < 20 degrees
Key exclusion criteria (4 listed)
- gout
- postraumatic arthritis
- osteonecrosis of knee
- inflammatory joint disease
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 |
|---|---|---|
| Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USAgender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male. | Procedure or surgery | Unisex knee prosthesis, patient specific knee prosthesis |
Primary outcome
anterior knee pain
Time frame: 4 years
Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
patellar tracking
Time frame: 4 years
patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking
1 secondary outcome
clinical outcome score
Time frame: 4 years
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 16 Sep 2021.
- 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.
Boonchana Pongcharoen, MD principal investigator
faculty of medicine, Thammasat university
Questions about this trial
What is this clinical trial studying?
A study testing Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA in people with Osteo Arthritis Knee and Knee Pain Chronic, run by Thammasat University.
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 5 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 16 Sep 2021. 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?
anterior knee pain (time frame: 4 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 16 Sep 2021.