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BPK-S Integration (Ceramic) Post Market Clinical Follow-Up

NCT ID: NCT03097471

Last Updated: 2017-03-31

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Restoration if Knee Joint Function

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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BPK-S Integration (Ceramic)

primary total knee endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klemens Trieb

OTHER

Sponsor Role lead

Responsible Party

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Klemens Trieb

Univ. Prof. Dr. Klemens Trieb

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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BPK-S-(pKK)-01-2011

Identifier Type: -

Identifier Source: org_study_id