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

• Sponsor: Peter Brehm GmbH (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02615522
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Actual Duration (Months): 50
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee; Joint Instability	Device: BPK-S Integration

Study Design

• Study Type: Observational
• Actual Enrollment: 124 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Outcome Measures

Primary Outcome Measures

1. Time until revision [10 years]

Secondary Outcome Measures

1. Improvement of clinical situation based on Knee Society Score [3 and 12 months, 2, 5, 10 years]

2. Documentation of incidents [Up to 10 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Landesklinikum Amstetten	Amstetten	Niederoesterreich	Austria	3300

Sponsors and Collaborators

• Peter Brehm GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Brehm GmbH
• ClinicalTrials.gov Identifier: NCT02615522
• Other Study ID Numbers: 2015-02-BPK-S Integration
• First Posted: Nov 26, 2015
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Peter Brehm GmbH: primary TKR
• Additional relevant MeSH terms: Osteoarthritis, Knee; Joint Instability

Study Results

No Results Posted as of Apr 20, 2022