Clinical Study of TM-Tibia/Patella

Clinical Study of TM-Tibia/Patella - Clinical Study of TM-Tibia/Patella

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004102

Enrollment

Registered

2010-08-25

Start date

2004-06-01

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

Patients with knee pain and dysfunction who have been diagnosed to require knee replacement

Interventions

Implantation of TM-Tibia/Patella by TKA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)A patient with knee pain and dysfunction who has been diagnosed to require total knee replacement and to be indicated for a cementless fixation at the tibial side. (2)A patient who understands the purpose of this clinical study and has provided a written consent. (3)A patient who may be followed up for 12 months postoperatively.

Exclusion criteria

Exclusion criteria: (1)A patient with a previous history of infection in the affected joint. (2)A patient with insufficient bone stock on tibial, femoral or patellar surfaces. (3)A patient with a skeletal immaturity. (4)A patient with neuropathic arthropathy. (5)A patient with infection-like symptoms. (6)A patient with rheumatoid arthritis with a previous history of skin ulcer or recurrent skin breakdown. (7)A patient with osteoporosis or a neuromuscular disease that may compromise the affected limbs. (8)A patient with severe instability secondary to absence of a collateral ligament. (9)A patient who has been judged ineligible for the conduct of the study by the study investigator.

Design outcomes

Primary

Measure	Time frame
(1)Efficacy evaluation Efficacy evaluation was performed using the following four categories of evaluation criteria based on the improvement rate by the JOA score and X-ray evaluation at 12 months postoperatively; Markedly effective, Effective, Slightly effective and Ineffective (2) Safety evaluation The clinical safety was evaluated based on the following four categories by comprehensively considering the adverse events; Safe, Almost safe, Insufficiently safe and Not safe (3) Usefulness evaluation The usefulness was judged according to the following five categories based on the matrix of efficacy and safety evaluation; Very useful, Useful,Slightly useful, Not useful and Contraindicated	—

Measure

Time frame

(1)Efficacy evaluation Efficacy evaluation was performed using the following four categories of evaluation criteria based on the improvement rate by the JOA score and X-ray evaluation at 12 months postoperatively; Markedly effective, Effective, Slightly effective and Ineffective (2) Safety evaluation The clinical safety was evaluated based on the following four categories by comprehensively considering the adverse events; Safe, Almost safe, Insufficiently safe and Not safe (3) Usefulness evaluation The usefulness was judged according to the following five categories based on the matrix of efficacy and safety evaluation; Very useful, Useful,Slightly useful, Not useful and Contraindicated

—

Countries

Japan

Contacts

Public ContactMikio Ishikawa

Zimmer K.K. Clinical Affairs

03-6402-6671

Outcome results

None listed

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