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TerminatedNCT02615522Updated Apr 20, 2022

Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

An observational study in Osteoarthritis, Knee and Joint Instability, sponsored by Peter Brehm GmbH. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Peter Brehm GmbH · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
124
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee
  • Joint Instability

Keywords

  • primary TKR
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
124 participants (actual)
Patient registry
No

Interventions

  • DeviceBPK-S Integration
05

What researchers measure

Primary outcomes

  1. Time until revision

    Time frame: 10 years

Secondary outcomes

  1. Improvement of clinical situation based on Knee Society Score

    Time frame: 3 and 12 months, 2, 5, 10 years

  2. Documentation of incidents

    Time frame: Up to 10 Years

06

Study locations

1 site
  • Landesklinikum Amstetten
    Amstetten, Niederoesterreich 3300, Austria
07

Registry details

Key details

Study ID
NCT02615522
Lead sponsor
Peter Brehm GmbH
Responsible party
Sponsor
First posted
Nov 26, 2015
Start date
Sep 2016
Primary completion
Nov 2020
Completion
Nov 2020
Last update
Apr 20, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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