Osteoarthritis, KneeNCT03406637
Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr
An observational study of Osteoarthritis, Knee and Joint Instability, run by Peter Brehm GmbH at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Joint Instability
- What is being tested?
- BPK-S Integration
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 2 sitesBelgium
- Study dates
- 17 Oct 2018to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator
Who may be able to join
- 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
Who cannot join
- No study specific exclusion criteria are defined for this PMCF study.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L
Tournai, 7500
Medical Center Tournai
Tournai, 7500
About this study
Official 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
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.
Read more
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
- Being tested
- BPK-S Integration
- Medical subject headings
- Osteoarthritis, Knee, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPK-S IntegrationDevice
primary total knee endoprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient relevant benefit after 5 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
Measured: 7 years
Secondary outcomes (8)
Safety parameters
Incidents that require reporting to the competent authority and complications during and after surgery as documented in source documentation
Measured: 7 years
Patient relevant benefit as measured by American Knee Society Score
improvement of KSS-Score as compared to preoperative basic assessment
Measured: 1 year
Implant Loosening Number
Number of implant loosening due to quality issues with the implant
Measured: 7 years
Implant Loosening Reason
Reason for implant loosening due to quality issues with the implant
Measured: 7 years
Revision Number
Number of revisions, if required
Measured: 7 years
Revision Reason
Reason for revision, if required
Measured: 7 years
Surgery Parameters
Evaluation of surgery time as documented in the surgical report
Measured: Day 0 = day of surgery
Surgery Parameters
Evaluation of tourniquet time as documented in the surgical report
Measured: Day 0 = day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start17 Oct 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Brehm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- P.R.I.S.M.A.-CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406637
- Sponsor's protocol ID
- 2016-01-BPK-S
- Status last verified
- Mar 2020
- First submitted
- 8 Jan 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03406637
- Acronym / sponsor ID
- 2016-01-BPK-S
- Conditions
- Osteoarthritis, Knee, Joint Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Peter Brehm GmbHIndustry (pharma, biotech, devices)
- Collaborators
- P.R.I.S.M.A.-CRO
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that received a BPK-S Integration in the variant CoCr as primary total knee endoprosthesis between 2011 and 2013 implanted by the investigator
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No study specific exclusion criteria are defined for this PMCF study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPK-S Integrationprimary total knee endoprosthesis | Device | – |
Primary outcome
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
8 secondary outcomes
Safety parameters
Time frame: 7 years
Patient relevant benefit as measured by American Knee Society Score
Time frame: 1 year
Implant Loosening Number
Time frame: 7 years
Implant Loosening Reason
Time frame: 7 years
Revision Number
Time frame: 7 years
Revision Reason
Time frame: 7 years
Surgery Parameters
Time frame: Day 0 = day of surgery
Surgery Parameters
Time frame: Day 0 = day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Joint Instability, run by Peter Brehm GmbH at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient relevant benefit after 5 years (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.