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

NCT04719195 | Unknown

• 1 other identifier: KC20OISI0561
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  changes from pre-operative Kellgren-Lawrence grade at post-operative 3rd month, 6th month and 1 year

• X-ray

  changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year

Interventions

Meniscus extrusion ultrasonogrphic evaluation OTHER

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

the Catholic Univerisity of Korea Seoul St Mary's hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yong Gyu Sung, MD

CONTACT

+82-10-9216-0997; ygsung@catholic.ackr

Yong In, MD, PhD

CONTACT

82-10-9044-5228; iy1000@catholic.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: July 25, 2020
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)