Knee Joint Diseases
Conditions
Interventions
None listed
Sponsors
Zimmer Biomet G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years and over. - Skeletally mature - Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent - Willing and able to complete scheduled follow-up evaluations as defined in the study protocol
Exclusion criteria
Exclusion criteria: - Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft - Is septic, has an active infection or has osteomyelitis at the affected joint and/or other local/systemic infection that may affect the prosthetic joint - Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery - Has any concomitant disease which is likely to jeopardize the functioning or success of the implant - Scheduled to undergo bilateral simultaneous TKA - Severe instability secondary to the absence of collateral ligament integrity - Pregnant patients, mentally ill patients, and other patients who the PIs determines may affect consent, safety, and evaluation - Is participating in any other surgical intervention studies or pain management studies at the time of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in 2011 KSS (Functional Knee Score) at 1 year after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| KSS 2011 (MCID, improvement rate, objective knee score), Range Of Motion, Gait Speed and asymmetry, incidence of soft tissue release and adverse event | — |
Countries
Japan
Contacts
Public ContactNoriko Sugawara
Zimmer Biomet G.K. Clinical Affairs
Outcome results
None listed