A randomized, prospective controlled pilot study between UKA and TKA

UMIN ID: UMIN000010221

Registered date:12/03/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bilateral Medial Knee Osteoarthritis
• Date of first enrollment: 2013/03/13
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Perform UKA first
Perform TKA first

Outcome(s)

• Primary Outcome: 2011 Knee Society Score
• Secondary Outcome: Radiographic Assessment, Clinical Assessments and Safety Assessment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1). Patient is currently participating in any other surgical intervention studies or pain management studies 2). Patient with previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint 3). Patient with insufficient bone stock on femoral or tibial surfaces 4). Patient with skeletal immaturity 5). Patient with neuropathic arthropathy 6). Patient with chondrocalcinosis 7). Patient with osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 8). Patient with damage to the articular cartilage of the opposite compartment 9). Patient with inflammatory synovitis 10). Patient with eburnation in the patellofemoral joint 11). Patient with a stable, painless arthrodesis in a satisfactory functional position 12). Patient with severe instability secondary to the absence of collateral ligament integrity 13). Patient with an ulcer of the skin or a history of recurrent breakdown of the skin 14). Patient with history of deep vein thrombosis (DVT) or pulmonary embolism (PE) 15). Patient has a known or suspected sensitivity or allergy to one or more of the implant materials 16). Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Related Information

• Primary Sponsor: Zimmer K.K.
• Source(s) of Monetary Support: Zimmer K.K.