NCT02615522
Terminated
N/A
Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Peter Brehm GmbH
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Time until revision
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time until revision
Time Frame: 10 years
Secondary Outcomes
- Improvement of clinical situation based on Knee Society Score(3 and 12 months, 2, 5, 10 years)
- Documentation of incidents(Up to 10 Years)
Study Sites (1)
Loading locations...
Similar Trials
Unknown
N/A
Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small ImplantsKNEE REPLACEMENTNCT04198389I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1,000
Unknown
N/A
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.HIP REPLACEMENTKNEE REPLACEMENTNCT04199377I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio500
Terminated
Phase 4
P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee SystemsOsteoarthritis, KneeNCT00208286DePuy International120
Terminated
N/A
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement SystemOsteoarthritis of the KneeNCT01820650Restor3D359
Terminated
N/A
Evaluation of the VEGA Knee System® Range of MotionPatients With Total Knee Arthroplasty Using the VEGA SystemNCT01768871Aesculap Implant Systems7