Skip to content

Comparison of 1-mm thickness variance polyethylene insert total knee arthroplasty system and 2-mm thickness variance polyethylene insert total knee arthroplasty system in the same patients

Comparison of 1-mm thickness variance polyethylene insert total knee arthroplasty system and 2-mm thickness variance polyethylene insert total knee arthroplasty system in the same patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006014
Enrollment
100
Registered
2021-03-19
Start date
2021-03-22
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This study is a prospective, single-centered, randomized controlled clinical trial. Patients undergoing bilateral total knee replacement arthroplasty(TKRA) for both knee osteoarthriti

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients aged 19 years or older who undergo total knee arthroplasty due to osteoarthritis of the knee joint ? Patients who have the will or ability to follow doctor's instructions, including rehabilitation treatment such as joint exercise ? Patients who understand this study and consent to participation in the study ? Adult patients with osteoarthritis of the knee joint (over 19 years old)

Exclusion criteria

Exclusion criteria: ? Patients with local infection, sepsis, neurological abnormality of the lower limb of the surgery site ? Patients with inflammatory arthritis or crystalline arthritis ? Patients with a history of surgery on one or both knees ? Patients with more than 20 degrees of preoperative flexion contracture, 15 degrees of varus deformity, 15 degrees of valgus deformation that may affect the balance of soft tissues and knee ligaments after surgery ? Patients with a range of motion of the knee joint below 90 degrees before surgery ? Highly obese patients with a body mass index of 40 or higher

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Index (WOMAC index)

Secondary

MeasureTime frame
Knee Society Score;Anterior and posterior stability;Simple knee X-ray;Range of Motion of Knee;Forgotten Joint Score (FJS)

Countries

Korea, Republic of

Contacts

Public ContactYong Gyu Sung

The Catholic University of Korea, Seoul St. Mary's Hospital

ygsung@catholic.ac.kr+82-2-2258-6369

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026