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Clinical Trials/NCT02615522
NCT02615522TerminatedNot Applicable

Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration

Peter Brehm GmbH1 site in 1 country124 target enrollmentStarted: September 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
124
Locations
1
Primary Endpoint
Time until revision
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Time until revision

Time Frame: 10 years

Secondary Outcomes

  • Improvement of clinical situation based on Knee Society Score(3 and 12 months, 2, 5, 10 years)
  • Documentation of incidents(Up to 10 Years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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