Comparison of Meniscus Extrusion Between Preoperative and Postoperative MOWHTO Using Ultrasonographic Assessment

Osteoarthritis, Knee Clinical Trial

Official title:

Comparison of Meniscus Extrusion Between Preoperative and Postoperative Medial Opening Wedge High Tibial Osteotomy by Using Ultrasonographic Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719195
• Other study ID #: KC20OISI0561
• Status: Recruiting
• Start date: July 25, 2020
• Est. completion date: July 24, 2022

Study information

• Verified date: January 2021
• Source: The Catholic University of Korea
• Contact: Yong Gyu Sung, MD
• Phone: +82-10-9216-0997
• Email: ygsung[@]catholic.ackr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 24, 2022
• Est. primary completion date: July 24, 2022
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Other:
• Meniscus extrusion ultrasonogrphic evaluation
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.

Locations

Country	Name	City	State
Korea, Republic of	the Catholic Univerisity of Korea Seoul St Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale		changes from pre-operative WOMAC score at post-operative 3rd month, 6th month and 1 year
Secondary	Pain Visual Analogue Scale		changes from pre-operative VAS score at post-operative 3rd month, 6th month and 1 year
Secondary	SF-12(Short Form heath survey) score		changes from pre-operative SF-12 score at post-operative 3rd month, 6th month and 1 year
Secondary	EQ-5D(EuroQoL-5 Dimension)		changes from pre-operative EQ-5D score at post-operative 3rd month, 6th month and 1 year
Secondary	X-ray	Kellgren-Lawrence grade	changes from pre-operative Kellgren-Lawrence grade at post-operative 3rd month, 6th month and 1 year
Secondary	X-ray	weight bearing line ratio	changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year
Secondary	Knee range of motion		changes from pre-operative knee range of motion at post-operative 3rd month, 6th month and 1 year
Secondary	Ultrasonographic evaluation of medial and lateral meniscus extrusion		changes from pre-operative ultrasonographic evaluation of medial and lateral meniscus extrusion at post-operative 3rd month, 6th month and 1 year