Knee OsteoarthritisNCT04518111
Oxford UKA and HTO Post-market Clinical Study
An observational study of Knee Osteoarthritis, run by Zimmer Biomet at 1 site in China.
Trial summary
The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2021to 31 Dec 2024
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent either primary UKA with Oxford Partial Knee with the Microplasty® instrumentation or Open Wedge HTO for AMOA, and meet the inclusion criteria and do not meet any exclusion criteria will be screened to this study.
Who may be able to join
- Patient is aged 18 to 85 years old, inclusive;
- Patients who diagnosed with AMOA of the knee, and have undergone Open Wedge HTO, or primary unilateral partial knee arthroplasty with Oxford Partial Knee with Microplasty® instrumentation in accordance to indications of UKA and the following radiographic assessments in the knee joint:
- exposed bone on both the femur and tibia in the medial compartment.
- functionally intact ACL
- full thickness lateral cartilage (ignore osteophytes)
- functionally normal MCL: correctable deformity (normal medial opening)
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- acceptable patellofemoral joint: normal, medial facet OA with or without bone loss, lateral facet OA without bone loss.
- UKA or HTO procedure completed one year prior to study participation;
- Patient provides written informed consent by signing and dating the Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent form.
Who cannot join
- Has undergone UKA but met any of the contraindications included in the product labeling of Oxford Partial Knee system;
- Has rheumatoid arthritis or other forms of inflammatory joint disease;
- Uncooperative or with neurologic disorders who are incapable of following directions;
- Has a diagnosed systemic disease that could affect his/her safety or the study outcome;
- Anterior cruciate ligament and posterior cruciate ligament injury, collateral ligament instability;
- Known to be pregnant;
- Prisoner or known alcohol / drug abuser.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population
The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome.
Read the detailed description
The purpose of this study is to compare the outcomes of medial UKA and HTO in the treatment of AMOA by investigating the performance of these 2 procedures in terms of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome, then identify factors associated with better clinical performance. It is aimed to provide evidence-based guidelines for selecting the appropriate procedure in managing AMOA in Chinese population based on the findings of this study.
The secondary endpoints will include:
- Pain Numerical Rating Scale (NRS)
- SF-12 Health Survey
- Radiographic assessment includes pre-op and post-op mechanical femorotibial angle (mFTA), patella height, patellofemoral medial and lateral articular surfaces, and displacement angle of patella
- Range of motion
- Adverse event rate and classification (including complication)
- Operating time
- Total blood loss (BRECHER formula)
- Revision rate
Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
- Conditions
- Knee Osteoarthritis
- Keywords
- Anteromedial osteoarthritis (AMOA)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unicompartmental Knee Arthroplasty (UKA) | Patients who underwent primary UKA with Oxford Partial Knee with the Microplasty® instrumentation for AMOA. | |
| High Tibial Osteotomy (HTO) | Patients who underwent Open Wedge HTO for AMOA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
Oxford Knee Score is a patient reported outcome measure questionnaire with a total score range from 0 (severe arthritis) to 48 (satisfactory joint function). The questionnaire contains 12 questions, each with five options scoring from 0 to 4 with 4 being the best outcome for each question.
Measured: 2 years
Secondary outcomes (5)
Numerical Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a measure of pain intensity in adults that consists of a numeric version of the visual analog scale numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain". Respondents select a whole one number between 0 and 10, which is best representative of their pain intensity with higher scores indicating greater pain intensity.
Measured: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
SF-12 Health Survey
The Short Form-12 Health Survey (SF-12) measures generic health concepts relevant across age, disease, and treatment groups. It was designed to measure general health status from the patient's point of view and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Two summary scores are reported from the SF-12, namely a mental component score (MCS-12) and a physical component score (PCS-12). All subscale scores were transformed to a 0 to 100 scale with the higher score indicating less dysfunction, impairment, or pain.
Measured: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Mechanical femorotibial angle (mFTA)
Mechanical femorotibial angle is a measurement that assess the mechanical alignment of the lower limb using the long-leg radiograph. It is the lesser angle intersecting the mechanical femoral axis (the line from the center of the femoral head to the knee center) and the mechanical tibial axis (the line from the knee center to the ankle center).
Measured: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Range of motion
Measurement of flexion and extension degree of the affected joint.
Measured: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Adverse event rate and classification
Summary of adverse events recorded during the study period, including complication and reoperation.
Measured: Intra-op, post-op 1 year and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start24 Apr 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Huang, Principal investigator, Beijing Chaoyang Emergency Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518111
- Sponsor's protocol ID
- CSA2019-47K
- Status last verified
- May 2024
- First submitted
- 11 Aug 2020
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population
- ClinicalTrials.gov ID
- NCT04518111
- Acronym / sponsor ID
- CSA2019-47K
- Conditions
- Knee Osteoarthritis
- Keywords
- Anteromedial osteoarthritis (AMOA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 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.
The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome.
Detailed description
The purpose of this study is to compare the outcomes of medial UKA and HTO in the treatment of AMOA by investigating the performance of these 2 procedures in terms of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome, then identify factors associated with better clinical performance. It is aimed to provide evidence-based guidelines for selecting the appropriate procedure in managing AMOA in Chinese population based on the findings of this study.
The secondary endpoints will include:
- Pain Numerical Rating Scale (NRS)
- SF-12 Health Survey
- Radiographic assessment includes pre-op and post-op mechanical femorotibial angle (mFTA), patella height, patellofemoral medial and lateral articular surfaces, and displacement angle of patella
- Range of motion
- Adverse event rate and classification (including complication)
- Operating time
- Total blood loss (BRECHER formula)
- Revision rate
Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicompartmental Knee Arthroplasty (UKA) | – | –Patients who underwent primary UKA with Oxford Partial Knee with the Microplasty® instrumentation for AMOA. |
| High Tibial Osteotomy (HTO) | – | –Patients who underwent Open Wedge HTO for AMOA. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent either primary UKA with Oxford Partial Knee with the Microplasty® instrumentation or Open Wedge HTO for AMOA, and meet the inclusion criteria and do not meet any exclusion criteria will be screened to this study.
Key inclusion criteria (9 listed)
- Patient is aged 18 to 85 years old, inclusive;
- Patients who diagnosed with AMOA of the knee, and have undergone Open Wedge HTO, or primary unilateral partial knee arthroplasty with Oxford Partial Knee with Microplasty® instrumentation in accordance to indications of UKA and the following radiographic assessments in the knee joint:
- UKA or HTO procedure completed one year prior to study participation;
- Patient provides written informed consent by signing and dating the Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent form.
Key exclusion criteria (7 listed)
- Has undergone UKA but met any of the contraindications included in the product labeling of Oxford Partial Knee system;
- Has rheumatoid arthritis or other forms of inflammatory joint disease;
- Uncooperative or with neurologic disorders who are incapable of following directions;
- Has a diagnosed systemic disease that could affect his/her safety or the study outcome;
- Anterior cruciate ligament and posterior cruciate ligament injury, collateral ligament instability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxford Knee Score
Time frame: 2 years
Oxford Knee Score is a patient reported outcome measure questionnaire with a total score range from 0 (severe arthritis) to 48 (satisfactory joint function). The questionnaire contains 12 questions, each with five options scoring from 0 to 4 with 4 being the best outcome for each question.
5 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
SF-12 Health Survey
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Mechanical femorotibial angle (mFTA)
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Range of motion
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Adverse event rate and classification
Time frame: Intra-op, post-op 1 year and 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- 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.
Ye Huang principal investigator
Beijing Chaoyang Emergency Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Zimmer Biomet at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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 China. 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?
Results are not available in the source record.
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?
Oxford Knee Score (time frame: 2 years). 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 23 May 2024.