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

• Conditions: Restoration if Knee Joint Function

• Registration Number: NCT03097471
• Lead Sponsor: Klemens Trieb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Study First Posted: 2017-03-31
• Last Update Posted: 2017-03-31
• Primary Completion: 2017-10
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of Knee Society Score	12 months

Secondary Outcome Measures

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