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OpenTrials
Completed

NCT Number: NCT03406637

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

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Joint Instability Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L, Tournai, Belgium

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria are defined for this PMCF study.

Treatment and study plan

BPK-S Integration

Device

primary total knee endoprosthesis

Primary outcomes

  1. Patient relevant benefit after 5 years

    Time frame: 7 years

    improvement of KSS-Score by at least one category as compared to preoperative basic assessment

Secondary outcomes

  1. Safety parameters

    Time frame: 7 years

    Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation

  2. Patient relevant benefit as measured by American Knee Society Score

    Time frame: 1 year

    improvement of KSS-Score as compared to preoperative basic assessment

  3. Implant Loosening Number

    Time frame: 7 years

    Number of implant loosening due to quality issues with the implant

  4. Implant Loosening Reason

    Time frame: 7 years

    Reason for implant loosening due to quality issues with the implant

  5. Revision Number

    Time frame: 7 years

    Number of revisions, if required

  6. Revision Reason

    Time frame: 7 years

    Reason for revision, if required

  7. Surgery Parameters

    Time frame: Day 0 = day of surgery

    Evaluation of surgery time as documented in the surgical report

  8. Surgery Parameters

    Time frame: Day 0 = day of surgery

    Evaluation of tourniquet time as documented in the surgical report

Sponsors and collaborators

Lead sponsor

Peter Brehm GmbH

Industry

Collaborators

  • P.R.I.S.M.A.-CRO

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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