OsteoarthritisNCT03293719
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
An observational study of Osteoarthritis and Osteoarthritis, Knee, run by Peter Brehm GmbH at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Joint Instability
- What is being tested?
- BPK-S Integration UC
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- 20 Mar 2018to 14 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older
Who may be able to join
- Congenital or acquired knee joint defects/deformation
- Defects or malfunction of the knee joint
- Arthrosis (degenerative, rheumatic)
- Post-traumatic arthritis
- Symptomatic knee instability
- Reconstruction of flexibility
- Patients with metal hypersensitivity (ceramic tibia/femur)
Who cannot join
- Illnesses which can be treated without using a knee joint implant.
- Acute or chronic infections near the implantation
- Systemic diseases and metabolic disorders
- Serious osteoporosis
- Serious damage to the bone structures that impedes stable implantation of the implant components
- Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.
Show all 15Show fewer
- Bone tumors in the area of the implant anchoring
- Obesity or overweight of the patient
- Overload of the knee implant to be expected
- Abuse of medication, drug abuse, alcoholism or mental disease
- Pregnancy
- Lack of patient cooperation
- Sensitivity to foreign matter in the implant materials
- Patients under the age of 18
- Patients participating in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- BPK-S Integration UC
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Joint Instability, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPK-S Integration UCDevice
Primary Knee Endoprosthesis
| Study group | Role | What they receive |
|---|---|---|
| Ceramic | Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic Receives: Device: BPK-S Integration UC | |
| CoCr | Patients receiving BPK-S Integration UC implant made from CoCr (metal) Receives: Device: BPK-S Integration UC |
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: 5 years
Secondary outcomes (7)
Patient relevant benefit as measured by American Knee Society Score
improvement of KSS-Score as compared to preoperative basic assessment
Measured: 3 months, 1, 2 and 5 years
Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score
Improvement of KOOS as compared to preoperative basic assessment
Measured: 3 months, 1, 2 and 5 years
Patient Quality of Life
Improvement of EQ-5D as compared to preoperative basic assessment
Measured: 3 months, 1, 2 and 5 years
Implant Loosening Number
Number of implant loosening due to quality issues with the implant
Measured: 3 months, 1, 2 and 5 years
Implant Loosening Reason
Reason for implant loosening due to quality issues with the implant
Measured: 3 months, 1, 2 and 5 years
Revision Number
Number of revisions, if required
Measured: 3 months, 1, 2 and 5 years
Revision Reason
Reason for revision, if required
Measured: 3 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start20 Mar 2018
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Why it stopped: Monocentric Study, Site reorganised, could no longer participate in study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 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
- Investigators
- Christian E. Berger, Prof., Principal investigator, Sozialmedizinisches Zentrum Ost - Donauspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293719
- Sponsor's protocol ID
- 2017-02-BPK-S Comparison
- Status last verified
- Nov 2019
- First submitted
- 19 Sep 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03293719
- Acronym / sponsor ID
- 2017-02-BPK-S Comparison
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Joint Instability, Arthritis, Joint Disease, Musculoskeletal Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Monocentric Study, Site reorganised, could no longer participate in study
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Peter Brehm GmbHIndustry (pharma, biotech, devices)
- Collaborators
- P.R.I.S.M.A.-CRO
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 26 Sep 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic | – | Device: BPK-S Integration UCPatients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic |
| CoCr | – | Device: BPK-S Integration UCPatients receiving BPK-S Integration UC implant made from CoCr (metal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older
Key inclusion criteria (7 listed)
- Congenital or acquired knee joint defects/deformation
- Defects or malfunction of the knee joint
- Arthrosis (degenerative, rheumatic)
- Post-traumatic arthritis
- Symptomatic knee instability
Key exclusion criteria (15 listed)
- Illnesses which can be treated without using a knee joint implant.
- Acute or chronic infections near the implantation
- Systemic diseases and metabolic disorders
- Serious osteoporosis
- Serious damage to the bone structures that impedes stable implantation of the implant components
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 Integration UCPrimary Knee Endoprosthesis | Device | Ceramic, CoCr |
Primary outcome
Patient relevant benefit after 5 years
Time frame: 5 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
7 secondary outcomes
Patient relevant benefit as measured by American Knee Society Score
Time frame: 3 months, 1, 2 and 5 years
Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score
Time frame: 3 months, 1, 2 and 5 years
Patient Quality of Life
Time frame: 3 months, 1, 2 and 5 years
Implant Loosening Number
Time frame: 3 months, 1, 2 and 5 years
Implant Loosening Reason
Time frame: 3 months, 1, 2 and 5 years
Revision Number
Time frame: 3 months, 1, 2 and 5 years
Revision Reason
Time frame: 3 months, 1, 2 and 5 years
Results and safety
The study was stopped early (reason given: Monocentric Study, Site reorganised, could no longer participate in study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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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.
Christian E. Berger, Prof. principal investigator
Sozialmedizinisches Zentrum Ost - Donauspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Osteoarthritis, Knee, run by Peter Brehm GmbH at 1 site in Austria.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 was stopped early (reason given: Monocentric Study, Site reorganised, could no longer participate in study). Results are not available in the source record.
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: 5 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 19 Nov 2019.