Trials / Terminated
TerminatedNCT03293719
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
Prospective, Open, Non-randomized, Non-interventional Explorative, Comparative, Uncontrolled Cohort Study for Post Market Clinical Follow-Up of the "BPK-S Integration" UC in the Variants CoCr or Ceramic as Primary Implant
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- Peter Brehm GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation). Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.
Conditions
- Osteoarthritis
- Osteoarthritis, Knee
- Joint Instability
- Arthritis
- Joint Disease
- Musculoskeletal Disease
- Rheumatic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BPK-S Integration UC | Primary Knee Endoprosthesis |
Timeline
- Start date
- 2018-03-20
- Primary completion
- 2019-10-14
- Completion
- 2019-10-14
- First posted
- 2017-09-26
- Last updated
- 2019-11-19
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03293719. Inclusion in this directory is not an endorsement.