Osteoarthritis, KneeNCT04719195
Comparison of Meniscus Extrusion Between Preoperative and Postoperative MOWHTO Using Ultrasonographic Assessment
An observational study of Osteoarthritis, Knee, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to measure the changes in the medial and lateral meniscus extrusion of the knee joint before and after surgery using ultrasound in patients who undergo medial opening wedge high tibial osteotomy, and examine the differences. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Meniscus extrusion ultrasonogrphic evaluation
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2020to 24 Jul 2022
- How long will I take part?
- 1 Year
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy
Who may be able to join
- Adults over 20
- Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Who cannot join
- Patients with secondary knee osteoarthritis
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients with knee range of motion less than 90 degrees
- Patients with BMI above 40
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
the Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul, 06591
Yong Gyu Sung, MD, 82-10-9216-0997, ygsung@catholic.ac.kr
About this study
Official title: Comparison of Meniscus Extrusion Between Preoperative and Postoperative Medial Opening Wedge High Tibial Osteotomy by Using Ultrasonographic Assessment
The purpose of this study is to measure the changes in the medial and lateral meniscus extrusion of the knee joint before and after surgery using ultrasound in patients who undergo medial opening wedge high tibial osteotomy, and examine the differences.
Read the detailed description
High tibial osteotomy (HTO) is an established treatment method for medial compartment osteoarthritis with varus knee deformity in a relatively young patient group. Excellent outcomes of HTO have been reported. However, about 10-30% of patients are not satisfied with the results after surgery. After proximal tibial osteotomy, studies on the factors of dissatisfaction have been actively conducted, but studies on the medial and lateral meniscus extrusion, which can be the cause, are insufficient. The relationship between the prolapse of the medial meniscus and articular cartilage is already well known and is known as an important factor in the progression of arthritis. As such, the association between the knee joint with meniscus extrusion and the general knee joint has been studied, but the effect on the clinical outcome after proximal tibial osteotomy has not been studied. Therefore, in this study, the investigators are planning to investigate the differences in clinical outcomes such as the degree and change of medial and lateral meniscus extrusion through non-invasive ultrasound examination before and after surgery in patients who undergo medial open proximal tibial osteotomy.
This study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Meniscus extrusion ultrasonogrphic evaluation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus extrusion ultrasonogrphic evaluationOther
This study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers.
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: changes from pre-operative WOMAC score at post-operative 3rd month, 6th month and 1 year
Secondary outcomes (7)
Pain Visual Analogue Scale
Measured: changes from pre-operative VAS score at post-operative 3rd month, 6th month and 1 year
SF-12(Short Form heath survey) score
Measured: changes from pre-operative SF-12 score at post-operative 3rd month, 6th month and 1 year
EQ-5D(EuroQoL-5 Dimension)
Measured: changes from pre-operative EQ-5D score at post-operative 3rd month, 6th month and 1 year
X-ray
Kellgren-Lawrence grade
Measured: changes from pre-operative Kellgren-Lawrence grade at post-operative 3rd month, 6th month and 1 year
X-ray
weight bearing line ratio
Measured: changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year
Knee range of motion
Measured: changes from pre-operative knee range of motion at post-operative 3rd month, 6th month and 1 year
Ultrasonographic evaluation of medial and lateral meniscus extrusion
Measured: changes from pre-operative ultrasonographic evaluation of medial and lateral meniscus extrusion at post-operative 3rd month, 6th month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jul 2020
- Primary completion24 Jul 2022 (estimated)
- Study completion24 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719195
- Sponsor's protocol ID
- KC20OISI0561
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 22 Jan 2021
- 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Meniscus Extrusion Between Preoperative and Postoperative Medial Opening Wedge High Tibial Osteotomy by Using Ultrasonographic Assessment
- ClinicalTrials.gov ID
- NCT04719195
- Acronym / sponsor ID
- KC20OISI0561
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 24 Jul 2022 (estimated)
- Study completion
- 24 Jul 2022 (estimated)
- First posted
- 22 Jan 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.
The purpose of this study is to measure the changes in the medial and lateral meniscus extrusion of the knee joint before and after surgery using ultrasound in patients who undergo medial opening wedge high tibial osteotomy, and examine the differences.
Detailed description
High tibial osteotomy (HTO) is an established treatment method for medial compartment osteoarthritis with varus knee deformity in a relatively young patient group. Excellent outcomes of HTO have been reported. However, about 10-30% of patients are not satisfied with the results after surgery. After proximal tibial osteotomy, studies on the factors of dissatisfaction have been actively conducted, but studies on the medial and lateral meniscus extrusion, which can be the cause, are insufficient. The relationship between the prolapse of the medial meniscus and articular cartilage is already well known and is known as an important factor in the progression of arthritis. As such, the association between the knee joint with meniscus extrusion and the general knee joint has been studied, but the effect on the clinical outcome after proximal tibial osteotomy has not been studied. Therefore, in this study, the investigators are planning to investigate the differences in clinical outcomes such as the degree and change of medial and lateral meniscus extrusion through non-invasive ultrasound examination before and after surgery in patients who undergo medial open proximal tibial osteotomy.
This study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy
Key inclusion criteria (4 listed)
- Adults over 20
- Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Key exclusion criteria (5 listed)
- Patients with secondary knee osteoarthritis
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients with knee range of motion less than 90 degrees
- Patients with BMI above 40
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 |
|---|---|---|
| Meniscus extrusion ultrasonogrphic evaluationThis study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers. | Other | – |
Primary outcome
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale
Time frame: changes from pre-operative WOMAC score at post-operative 3rd month, 6th month and 1 year
7 secondary outcomes
Pain Visual Analogue Scale
Time frame: changes from pre-operative VAS score at post-operative 3rd month, 6th month and 1 year
SF-12(Short Form heath survey) score
Time frame: changes from pre-operative SF-12 score at post-operative 3rd month, 6th month and 1 year
EQ-5D(EuroQoL-5 Dimension)
Time frame: changes from pre-operative EQ-5D score at post-operative 3rd month, 6th month and 1 year
X-ray
Time frame: changes from pre-operative Kellgren-Lawrence grade at post-operative 3rd month, 6th month and 1 year
X-ray
Time frame: changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year
Knee range of motion
Time frame: changes from pre-operative knee range of motion at post-operative 3rd month, 6th month and 1 year
Ultrasonographic evaluation of medial and lateral meniscus extrusion
Time frame: changes from pre-operative ultrasonographic evaluation of medial and lateral meniscus extrusion at post-operative 3rd month, 6th month and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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.
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 Osteoarthritis, Knee, run by The Catholic University of Korea at 1 site in South 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. 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 South Korea. 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?
Contact Yong Gyu Sung, MD (+82-10-9216-0997, ygsung@catholic.ackr), 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: changes from pre-operative WOMAC score at post-operative 3rd month, 6th month and 1 year). 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 22 Jan 2021.