Restoration if Knee Joint FunctionNCT03097471
BPK-S Integration (Ceramic) Post Market Clinical Follow-Up
An observational study of Restoration if Knee Joint Function, run by Klemens Trieb.
Trial summary
Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Restoration if Knee Joint Function
- What is being tested?
- BPK-S Integration (Ceramic)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who routinely receive an BKP-S Integration implant made of ceramic are asked to participate.
Who may be able to join
- Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
- Defects or malfunctions of the knee joint
- Degenerative, rheumatic, post-traumatic arthritis/arthrosis
- Symptomatic knee instability
- Reconstruction of flexibility
- Patients with material hypersensitivity
Who cannot join
- Obesity or overweight of the patient
- Acute or chronic infections near the implantation
- Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
- Sensitivity to foreign matter in the implant materials
- Bone tumors in the area of the implant anchoring
- Illnesses which can be treated without using a knee implant
Show all 13Show fewer
- Lack of patient cooperation
- Abuse of medication, drug abuse, alcoholism or mental disease
- Pregnancy
- Serious osteoporosis
- Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
- Systemic diseases and metabolic disorders
- Overload of the knee implant to be expected
About this study
Official title: Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta
Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.
- Conditions
- Restoration if Knee Joint Function
- Being tested
- BPK-S Integration (Ceramic)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPK-S Integration (Ceramic)Device
primary total knee endoprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Knee Society Score
Measured: 12 months
Secondary outcomes (4)
Improvement of Knee Society Score over the course of the study
Measured: 3 months, 24 months
Improvement of EQ-5D (Euroquol 5 dimension) score
Measured: 3 month, 12 months, 24 months
Improvement of Oxford Score
Measured: 3 month, 12 months, 24 months
Documentation of Complications
Measured: 3 month, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startMay 2011
- Primary completionOct 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration if Knee Joint FunctionStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klemens Trieb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klemens Trieb, Klinikum Wels-Grieskirchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097471
- Sponsor's protocol ID
- BPK-S-(pKK)-01-2011
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta
- ClinicalTrials.gov ID
- NCT03097471
- Acronym / sponsor ID
- BPK-S-(pKK)-01-2011
- Conditions
- Restoration if Knee Joint Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Klemens TriebUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 31 Mar 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.
Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who routinely receive an BKP-S Integration implant made of ceramic are asked to participate.
Key inclusion criteria (6 listed)
- Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
- Defects or malfunctions of the knee joint
- Degenerative, rheumatic, post-traumatic arthritis/arthrosis
- Symptomatic knee instability
- Reconstruction of flexibility
Key exclusion criteria (13 listed)
- Obesity or overweight of the patient
- Acute or chronic infections near the implantation
- Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
- Sensitivity to foreign matter in the implant materials
- Bone tumors in the area of the implant anchoring
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 (Ceramic)primary total knee endoprosthesis | Device | – |
Primary outcome
Improvement of Knee Society Score
Time frame: 12 months
4 secondary outcomes
Improvement of Knee Society Score over the course of the study
Time frame: 3 months, 24 months
Improvement of EQ-5D (Euroquol 5 dimension) score
Time frame: 3 month, 12 months, 24 months
Improvement of Oxford Score
Time frame: 3 month, 12 months, 24 months
Documentation of Complications
Time frame: 3 month, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Restoration if Knee Joint Function, run by Klemens Trieb.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Improvement of Knee Society Score (time frame: 12 months). 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 31 Mar 2017.