Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

NCT03293719 | Terminated DMC

• 1 other identifier: 2017-02-BPK-S Comparison
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation). Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.

Conditions

Osteoarthritis; Osteoarthritis, Knee; Joint Instability; Arthritis; Joint Disease; Musculoskeletal Disease; Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• Patient relevant benefit after 5 years

  improvement of KSS-Score by at least one category as compared to preoperative basic assessment

  5 years

Secondary Outcomes (7)

• Patient relevant benefit as measured by American Knee Society Score

  3 months, 1, 2 and 5 years

• Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score

  3 months, 1, 2 and 5 years

• Patient Quality of Life

  3 months, 1, 2 and 5 years

• Implant Loosening Number

  3 months, 1, 2 and 5 years

• Implant Loosening Reason

  3 months, 1, 2 and 5 years

Study Arms (2)

Ceramic

Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic

Device: BPK-S Integration UC

CoCr

Patients receiving BPK-S Integration UC implant made from CoCr (metal)

Device: BPK-S Integration UC

Interventions

BPK-S Integration UC DEVICE

Primary Knee Endoprosthesis

Ceramic; CoCr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Congenital or acquired knee joint defects/deformation
• Defects or malfunction of the knee joint
• Arthrosis (degenerative, rheumatic)
• Post-traumatic arthritis
• Symptomatic knee instability
• Reconstruction of flexibility
• Patients with metal hypersensitivity (ceramic tibia/femur)

You may not qualify if:

• 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
• Pregnancy
• Lack of patient cooperation
• Sensitivity to foreign matter in the implant materials
• Patients under the age of 18
• Patients participating in another trial

Sponsors & Collaborators

• Peter Brehm GmbH: lead
• P.R.I.S.M.A.-CRO: collaborator

Study Sites (1)

SMZ Ost, Donauspital

Vienna, Upper Austria, 1220, Austria

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Joint Instability; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christian E. Berger, Prof.

  Sozialmedizinisches Zentrum Ost - Donauspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: March 20, 2018
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

AU (1)