Knee Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Zimmer Biomet G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 18 years and over. (2) When using bone filling material, patients who use Affinos in compliance with the IFU (whether or not to use bone filling material or autograft is entrusted to surgeons). (3) Willing and able to complete scheduled follow-up evaluations as described in the study protocol. (4) Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent.
Exclusion criteria
Exclusion criteria: (1) Is septic, has an active infection or has osteomyelitis at the affected joint. (2) Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery. (3) Has any concomitant disease which is likely to jeopardize the functioning or success of the implant. (4) Scheduled for surgery may affect implant evaluation (including Anterior Cruciate Ligament (ACL) reconstruction). (5) Underwent Double Level Osteotomy (DLO). (6) Has been enrolled to this study with contralateral knee. (7) Is known to be pregnant. (8) Unable to understand what participation in this study entails. (9) Has a known sensitivity or allergy to one or more of the implanted materials. (10) Others deemed inappropriate by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Device Deficiency and Adverse Event for which the causal relationship with study device cannot be denied. | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of improvement in knee function, knee pain, and quality of life (QOL) as well as the relationship between the plate and irritation. | — |
Countries
Japan
Contacts
Public ContactAkira Kashima
Zimmer Biomet G.K. Clinical Affairs
Outcome results
None listed