BPK-S Integration (Ceramic) Post Market Clinical Follow-Up

Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta

Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.

Study Overview

• Status: Unknown
• Conditions: Restoration if Knee Joint Function
• Intervention / Treatment: Device: BPK-S Integration (Ceramic)

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who routinely receive an BKP-S Integration implant made of ceramic are asked to participate.

Description

Inclusion Criteria:

• Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
• Defects or malfunctions of the knee joint
• Degenerative, rheumatic, post-traumatic arthritis/arthrosis
• Symptomatic knee instability
• Reconstruction of flexibility
• Patients with material hypersensitivity

Exclusion Criteria:

• Obesity or overweight of the patient
• Acute or chronic infections near the implantation
• Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
• Sensitivity to foreign matter in the implant materials
• Bone tumors in the area of the implant anchoring
• Illnesses which can be treated without using a knee implant
• Lack of patient cooperation
• Abuse of medication, drug abuse, alcoholism or mental disease
• Pregnancy
• Serious osteoporosis
• Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
• Systemic diseases and metabolic disorders
• Overload of the knee implant to be expected

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of Knee Society Score	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of Knee Society Score over the course of the study	3 months, 24 months
Improvement of EQ-5D (Euroquol 5 dimension) score	3 month, 12 months, 24 months
Improvement of Oxford Score	3 month, 12 months, 24 months
Documentation of Complications	3 month, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Klemens Trieb

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BPK-S-(pKK)-01-2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No