CERAMENT™| Bone Void Filler Device Registry

N/ARecruitingNCT04244942

BONESUPPORT AB300 enrolled

Overview

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Orthopedic Disorder

Interventions

CERAMENT BVFDEVICE

CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years and over (on the day of surgery) * Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product * In receipt of patient information leaflet and have signed appropriately designed informed consent Exclusion Criteria: * Any exclusion criteria as per IFU for CERAMENT BVF * Any off-label use

Locations (13)

HonorHealth

Scottsdale, Arizona, United States

RECRUITING

Golden Orthopedic Knee, Hip, Shoulder and Foot Center

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Time frame: 12 months

Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Time frame: 18 months

Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Time frame: 12 months

Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Time frame: 18 months

Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Time frame: 12 and 18 months

Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months

Central Contacts

Brian M Bartholdi

CONTACT

6178923927 brian.bartholdi@bonesupport.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Radiological assessment at 6 and 12 months. Objective assessment of regeneration

Bone healing

Time frame: 6 Months

Radiological assessment at 6 and 12 months. Objective assessment of regeneration

Bone healing

Time frame: 12 Months

Pain VAS score

Pain assessment at 6,12, and 18 months

Time frame: 6, 12, and 18 Months

EQ-5D-3L

Functional assessment at 6, 12, and 18 months

Time frame: 6, 12, and 18 months