Surgical Joint Replacement: Primary complete or partial / unicompartmental knee arthroplasty or hip arthroplasty.
Conditions
Interventions
Group 1: Data of the study will be collected as part of the scheduled appointments before and after artificial knee or hip replacement surgery, respectively. Patients will fill out two questionnaires
Sponsors
OSARTIS GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged between 18 – 85 years (on the day of screening ) 2) Patient requires primary total or partial/unicompartmental knee ar-throplasty or hip arthroplasty 3) Planned routine radiographs at 12 ± 2 months after the intervention 4) Patient has signed written Informed Consent 5) Subjects able and willing to attend all scheduled visits and comply with all study procedures
Exclusion criteria
Exclusion criteria: 1) Bilateral surgical intervention 2) Severe generalized disease resulting in a life expectancy shorter than 12 months 3) Pregnant or breast-feeding women (urine pregnancy test) 4) Women of childbearing potential without effective contraception 5) Alcohol- or drug abuse (clinical manifestation) 6) Subjects with psychiatric disorders influencing their judgement or autonomy 7) Inability or unwillingness to understand or comply with required study procedures 8) Subjects who are not suitable for the study based on the principal investigator’s evaluation 9) Muscle wasting or neuromuscular compromise in the affected limb renders the procedure unjustifiable. 10) Known hypersensitivity to any of its constituents 11) Patients with severe renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As clinical safety endpoint frequency and severity of adverse events, incidences and interactions are recorded. Safety data are monitored and rec-orded for all patients regardless of indication subgroups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of implant positioning by standing anteroposterior and / or lateral radiographs 2. Need for revision including reason for revision 3. Usability assessment by the treating surgeon 4. Performance assessment for the subgroup hip arthroplasty: HHS 5. Performance assessment for the subgroup knee arthroplasty: OKS | — |
Countries
Germany
Contacts
Public ContactIna Hallstein
OSARTIS GmbH
Outcome results
None listed