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| Name | Class |
|---|---|
| P.R.I.S.M.A.-CRO | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPK-S Integration | Device | primary total knee endoprosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Patient relevant benefit after 5 years | improvement of KSS-Score by at least one category as compared to preoperative basic assessment | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters | Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation | 7 years |
| Patient relevant benefit as measured by American Knee Society Score |
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Inclusion Criteria:
Exclusion Criteria:
No study specific exclusion criteria are defined for this PMCF study.
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Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L | Tournai | 7500 | Belgium | |||
| Medical Center Tournai |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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improvement of KSS-Score as compared to preoperative basic assessment
| 1 year |
| Implant Loosening Number | Number of implant loosening due to quality issues with the implant | 7 years |
| Implant Loosening Reason | Reason for implant loosening due to quality issues with the implant | 7 years |
| Revision Number | Number of revisions, if required | 7 years |
| Revision Reason | Reason for revision, if required | 7 years |
| Surgery Parameters | Evaluation of surgery time as documented in the surgical report | Day 0 = day of surgery |
| Surgery Parameters | Evaluation of tourniquet time as documented in the surgical report | Day 0 = day of surgery |
| Tournai |
| 7500 |
| Belgium |
| D012216 |
| Rheumatic Diseases |