iASSIST study

JRCT ID: jRCTs032180377

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Osteoarthritis
• Date of first enrollment: 18/08/2017
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Investigational group: Persona TKA with iASSIST Knee as the Investigational group
Control group: Persona TKA with conventional instrumentation and without iASSIST Knee as the Control group

Outcome(s)

• Primary Outcome: The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.

Secondary Outcome

Health Status assessed with the EQ-5D form
Surgery time from skin incision to closure
Any adverse events (including device related, non-device related, procedure related, non-procedure related)
Number of instrument trays used

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
Male or female
At least 20 years of age
Patients willing to return for follow-up evaluations.

Exclude criteria

Absolute contraindications include:
Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
Too severe OA deformation (FTA: > 190 degrees/< 175 degrees)
Active infection (or within 6 weeks after infection)
Sepsis
Osteomyelitis
Any type of implant is inserted in the affected side of lower extremity
Hip and/or foot disease on the affected side

Additional contraindications include:
Uncooperative patient or patient with neurologic disorders who are incapable of following directions
Diagnosed osteoporosis or osteomalacia
Metabolic disorders which may impair bone formation
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Vascular insufficiency, muscular atrophy or neuromuscular disease.

Related Information

• Primary Sponsor: Ohdera Toshihiro
• Source(s) of Monetary Support: Zimmer Biomet G.K.
• Secondary ID(s): NCT03227692/ UMIN000027545