Joint Instability, Osteoarthritis, Knee
Conditions
Brief summary
Patients who received a total knee endoprosthesis BPK-S Integration between 2011 and 2013 will be invited to participate in this PMCF study provided sufficient source data documentation is available regarding preoperative, intraoperative and early postoperative follow-up assessments. Only patients providing written informed consent prior to any study data collection can take part in the study. Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after implantation) will be collected retrospectively. Additional long-term follow-up of one visit (year 7 after implantation) will be documented prospectively. Only parameters assessed in clinical standard care for follow-up (implant control) visits will be collected for this PMCF study. Radiological assessment of the implanted prosthesis will only be conducted if medically indicated according to the investigator. No additional study related assessment will be performed. Only anonymized data will be used in this observational study to protect patient privacy. No personally identifiable information will be collected.
Interventions
DEVICEBPK-S Integration
primary total knee endoprosthesis
Sponsors
P.R.I.S.M.A.-CRO
Peter Brehm GmbH
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients that received a total primary knee endoprosthesis BPK-S Integration (Co28Cr6Mo) between 2011 and 2013 * Patients that agree to participate and give written informed consent to the anonymized retrospective and prospective data collection within the study
Exclusion criteria
No study specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient relevant benefit after 5 years | 7 years | improvement of KSS-Score by at least one category as compared to preoperative basic assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters | 7 years | Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation |
| Patient relevant benefit as measured by American Knee Society Score | 1 year | improvement of KSS-Score as compared to preoperative basic assessment |
| Implant Loosening Number | 7 years | Number of implant loosening due to quality issues with the implant |
| Implant Loosening Reason | 7 years | Reason for implant loosening due to quality issues with the implant |
| Revision Number | 7 years | Number of revisions, if required |
| Revision Reason | 7 years | Reason for revision, if required |
| Surgery Parameters | Day 0 = day of surgery | Evaluation of surgery time as documented in the surgical report |
Countries
Belgium
Outcome results
None listed