The study of prosthesis design in TKA

JRCT ID: jRCTs012180025

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 07/09/2017
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Intraoperative measurement by using different design of component trial.( four times)

Outcome(s)

• Primary Outcome: Intraoperative patellofemoral joint contact pressure obtained by using different patella component design.
• Secondary Outcome: Subjective and objective clinical outcomes (p.o. 1y and 2y)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Total knee arthroplasty will be performed for primary OA
2. Patient has given consent to participate in the study.
4. more than 20 years old and less than 80 years old

Exclude criteria

1. Bone quality (tibia and femur) is insufficient.
2. Patient is immunosuppressed or has an autoimmune immunodeficient disorder.
3. Patient has an autoimmune disorder.
4. Patient has had major, non-arthroscopic surgery to the study knee.
5. Patient has an active, local infection or systemic infection.
6. Patient has a physical, emotional or neurological condition that would compromise compliance with postoperative rehabilitation and follow up.
7. Patient has hip inflammatory arthritis or performed THA.
8. Lateral knee OA
9. Patient is pregnant or plans to pregnant during course of study.
10. Patient is on workman's compensation.
11. Serious medical infirmity.
12. Symptomatic spinal disease.
13. more than 80 years old

Related Information

• Primary Sponsor: Onodera Tomohiro
• Source(s) of Monetary Support: Johnson &amp; Johnson
• Secondary ID(s): UMIN000020380