Clinical trial NCT03293719: Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Osteoarthritis, Knee
Joint Instability
Arthritis
Joint Disease
Musculoskeletal Disease
Rheumatic Diseases
Lead sponsor: Peter Brehm GmbH
Sponsor class: INDUSTRY
Collaborators: name: P.R.I.S.M.A.-CRO
First posted: 2017-09-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

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
* Pregnancy
* Lack of patient cooperation
* Sensitivity to foreign matter in the implant materials
* Patients under the age of 18
* Patients participating in another trial

Primary outcomes:
measure: Patient relevant benefit after 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Patient relevant benefit as measured by American Knee Society Score
timeFrame: 3 months, 1, 2 and 5 years
measure: Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score
timeFrame: 3 months, 1, 2 and 5 years
measure: Patient Quality of Life
timeFrame: 3 months, 1, 2 and 5 years
measure: Implant Loosening Number
timeFrame: 3 months, 1, 2 and 5 years
measure: Implant Loosening Reason
timeFrame: 3 months, 1, 2 and 5 years
measure: Revision Number
timeFrame: 3 months, 1, 2 and 5 years
measure: Revision Reason
timeFrame: 3 months, 1, 2 and 5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: SMZ Ost, Donauspital
state: Oberösterreich
Study officials:
affiliation: Sozialmedizinisches Zentrum Ost - Donauspital
name: Christian E. Berger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: