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A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component

A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component - Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043422
Enrollment
100
Registered
2021-02-23
Start date
2021-03-03
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component

Interventions

Standard cementless total knee arthroplasty cemented TKA

Sponsors

Fujita health university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients giving voluntary written informed consent to participate in the study Patients aged 50 years or older Patients undergoing initial TKA Osteoarthritis (OA), rheumatoid arthritis (RA), idiopathic osteonecrosis of the medial femoral condyle

Exclusion criteria

Exclusion criteria: Patients who cannot attend postoperative follow-up at Months 1, 3, 6, and Year 1 Patients not suitable for Persona TM tibia (large bone defect, ligament imbalance, damage to posterior cruciate ligament, revision TKA) Patients whom the investigator/sub-investigator consider unsuitable for this study

Design outcomes

Primary

MeasureTime frame
Changes in bone near the peg by plain X-ray

Secondary

MeasureTime frame
Changes in bone density near the tibial peg over time

Countries

Japan

Contacts

Public ContactKaszue Hayakawa

Fujita health university school of medicine Orthopedics

hkazue@fujita-hu.ac.jp+81562932169

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026