Status:
TERMINATED
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
Lead Sponsor:
Peter Brehm GmbH
Collaborating Sponsors:
P.R.I.S.M.A.-CRO
Conditions:
Osteoarthritis
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
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 cerami...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03293719
Start Date
March 20 2018
End Date
October 14 2019
Last Update
November 19 2019
Active Locations (1)
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1
SMZ Ost, Donauspital
Vienna, Upper Austria, Austria, 1220