- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615522
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Niederoesterreich
-
Amstetten, Niederoesterreich, Austria, 3300
- Landesklinikum Amstetten
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time until revision
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of clinical situation based on Knee Society Score
Time Frame: 3 and 12 months, 2, 5, 10 years
|
3 and 12 months, 2, 5, 10 years
|
Documentation of incidents
Time Frame: Up to 10 Years
|
Up to 10 Years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-02-BPK-S Integration
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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