NIPH Clinical Trials Search

UMIN ID: UMIN000010221

Registered date:12/03/2013

A randomized, prospective controlled pilot study between UKA and TKA

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBilateral Medial Knee Osteoarthritis
Date of first enrollment2013/03/13
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Perform UKA first Perform TKA first


Primary Outcome2011 Knee Society Score
Secondary OutcomeRadiographic Assessment, Clinical Assessments and Safety Assessment

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1). 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


public contact
Name Akira Kashima
Address 1-17, Toranomon 4-chome Minato-ku, Tokyo, Japan Japan
Telephone 03-6402-6610
Affiliation Zimmer K.K. Clinical Affairs
scientific contact
Name Kiyonori Mizuno
Address 4-12, Minatojima 1-chome, Minami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan Japan
Telephone 078-304-5252
Affiliation Anshin Hospital Orthopedic Surgery