Osteoarthritis, KneeNCT02615522
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
An observational study of Osteoarthritis, Knee and Joint Instability, run by Peter Brehm GmbH at 1 site in Austria.
Trial summary
Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark. 200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. 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
- 124 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2016to Nov 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
- 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 or
- Defects or malfunction of the knee joint or
- Arthrosis (degenerative, rheumatic) or
- Post-traumatic arthritis or
- Symptomatic knee instability or
- Reconstruction of flexibility or
- 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 14Show 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
- 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: Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.
200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.
- Conditions
- Osteoarthritis, Knee, Joint Instability
- Being tested
- BPK-S Integration
- Keywords
- primary TKR
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until revision
Measured: 10 years
Secondary outcomes (2)
Improvement of clinical situation based on Knee Society Score
Measured: 3 and 12 months, 2, 5, 10 years
Documentation of incidents
Measured: Up to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startSep 2016
- Primary completionNov 2020
- Study completionNov 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
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Brehm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615522
- Sponsor's protocol ID
- 2015-02-BPK-S Integration
- Status last verified
- Apr 2022
- First submitted
- 20 Nov 2015
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
- ClinicalTrials.gov ID
- NCT02615522
- Acronym / sponsor ID
- 2015-02-BPK-S Integration
- Conditions
- Osteoarthritis, Knee, Joint Instability
- Keywords
- primary TKR
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Peter Brehm GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 26 Nov 2015 (estimated)
- 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, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.
200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 or
- Defects or malfunction of the knee joint or
- Arthrosis (degenerative, rheumatic) or
- Post-traumatic arthritis or
- Symptomatic knee instability or
Key exclusion criteria (14 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 | Device | – |
Primary outcome
Time until revision
Time frame: 10 years
2 secondary outcomes
Improvement of clinical situation based on Knee Society Score
Time frame: 3 and 12 months, 2, 5, 10 years
Documentation of incidents
Time frame: Up to 10 Years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
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, Knee and Joint Instability, 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 14 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 20 Apr 2022. 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. 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?
Time until revision (time frame: 10 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 20 Apr 2022.