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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

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's enrollment of 124 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Peter Brehm GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

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

Interventions

  • DeviceBPK-S Integration
06

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

07

Study locations

1 site
  • Landesklinikum Amstetten
    Amstetten, Niederoesterreich 3300, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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