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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02615522

Enrollment

124

Registered

2015-11-26

Start date

2016-09-30

Completion date

2020-11-30

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Instability, Osteoarthritis, Knee

Keywords

primary TKR

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.

Interventions

DEVICEBPK-S Integration

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time until revision	10 years

Secondary

Measure	Time frame
Improvement of clinical situation based on Knee Society Score	3 and 12 months, 2, 5, 10 years
Documentation of incidents	Up to 10 Years

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026