Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2019-10-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Osteoarthritis, Knee Joint Instability Arthritis Joint Disease Musculoskeletal Disease Rheumatic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ceramic

Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic

BPK-S Integration UC

Intervention Type DEVICE

Primary Knee Endoprosthesis

CoCr

Patients receiving BPK-S Integration UC implant made from CoCr (metal)

BPK-S Integration UC

Intervention Type DEVICE

Primary Knee Endoprosthesis

Interventions

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BPK-S Integration UC

Primary Knee Endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No