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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Meniscus extrusion ultrasonogrphic evaluation

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • the Catholic Univerisity of Korea Seoul St Mary's hospital
    • Contact: Yong Gyu Sung, MD; Phone Number: 82-10-9216-0997; Email: ygsung@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analogue Scale		changes from pre-operative VAS score at post-operative 3rd month, 6th month and 1 year
SF-12(Short Form heath survey) score		changes from pre-operative SF-12 score at post-operative 3rd month, 6th month and 1 year
EQ-5D(EuroQoL-5 Dimension)		changes from pre-operative EQ-5D score at post-operative 3rd month, 6th month and 1 year
X-ray	Kellgren-Lawrence grade	changes from pre-operative Kellgren-Lawrence grade at post-operative 3rd month, 6th month and 1 year
X-ray	weight bearing line ratio	changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year
Knee range of motion		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		changes from pre-operative ultrasonographic evaluation of medial and lateral meniscus extrusion at post-operative 3rd month, 6th month and 1 year

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Anticipated): July 24, 2022
• Study Completion (Anticipated): July 24, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KC20OISI0561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No