Restoration if Knee Joint Function
Conditions
Brief 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.
Interventions
DEVICEBPK-S Integration (Ceramic)
primary total knee endoprosthesis
Sponsors
Klemens Trieb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of Knee Society Score | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Knee Society Score over the course of the study | 3 months, 24 months |
| Improvement of EQ-5D (Euroquol 5 dimension) score | 3 month, 12 months, 24 months |
| Improvement of Oxford Score | 3 month, 12 months, 24 months |
| Documentation of Complications | 3 month, 12 months, 24 months |
Outcome results
None listed