NCT03406637

Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr

Combined Prospective / Retrospective, Open, Non-randomized, Non-interventional Post Market Clinical Follow-Up of the BPK-S Integration System (Co28Cr6Mo) Used for Primary Total Knee Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Peter Brehm GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Osteoarthritis, Knee
• Joint Instability

Interventions

Type	Name	Description
DEVICE	BPK-S Integration	primary total knee endoprosthesis

Timeline

• Start date: 2018-10-17
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2018-01-23
• Last updated: 2020-03-06

Locations

2 sites across 1 country: Belgium