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

NCT02615522 | Terminated

• 1 other identifier: 2015-02-BPK-S Integration
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Joint Instability

Keywords

primary TKR

Outcome Measures

Primary Outcomes (1)

• Time until revision

  10 years

Secondary Outcomes (2)

• Improvement of clinical situation based on Knee Society Score

  3 and 12 months, 2, 5, 10 years

• Documentation of incidents

  Up to 10 Years

Interventions

BPK-S Integration DEVICE

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 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)

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
• 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

Study Sites (1)

Landesklinikum Amstetten

Amstetten, Lower Austria, 3300, Austria

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Instability

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 26, 2015
• Study Start: September 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

AU (1)