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Clinical Trials/NCT03097471
NCT03097471
Unknown
Not Applicable

Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta

Klemens Trieb0 sites40 target enrollmentMay 2011
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ConditionsRestoration if Knee Joint Function

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Restoration if Knee Joint Function
Sponsor
Klemens Trieb
Enrollment
40
Primary Endpoint
Improvement of Knee Society Score
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
March 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Klemens Trieb

Univ. Prof. Dr. Klemens Trieb

Klinikum Wels-Grieskirchen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement of Knee Society Score

Time Frame: 12 months

Secondary Outcomes

  • Improvement of EQ-5D (Euroquol 5 dimension) score(3 month, 12 months, 24 months)
  • Documentation of Complications(3 month, 12 months, 24 months)
  • Improvement of Knee Society Score over the course of the study(3 months, 24 months)
  • Improvement of Oxford Score(3 month, 12 months, 24 months)

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