Clinical trial NCT04244942: CERAMENT™| Bone Void Filler Device Registry
Official title: CERAMENT™| Bone Void Filler Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Disorder
Lead sponsor: BONESUPPORT AB
Sponsor class: INDUSTRY
First posted: 2020-01-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The racial, gender, and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily received CERAMENT BVF for the treatment of their condition at the designated investigative centers. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender or sexuality.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 12 and 18 months
measure: 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
timeFrame: 12 months
measure: adverse device 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
timeFrame: 18 months
measure: SAEs 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
timeFrame: 12 months
measure: SAEs 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
timeFrame: 18 months
Secondary outcomes:
measure: Radiological assessment at 6 and 12 months. Objective assessment of regeneration
timeFrame: 6 Months
measure: Radiological assessment at 6 and 12 months. Objective assessment of regeneration
timeFrame: 12 Months
measure: Pain VAS score
timeFrame: 6, 12, and 18 Months
measure: EQ-5D-3L
timeFrame: 6, 12, and 18 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Boca Raton
country: United States
facility: Golden Orthopedic Knee, Hip, Shoulder and Foot Center
state: Florida
city: Boca Raton
country: United States
facility: Sports and Orthopedic Center
state: Florida
city: Pompano Beach
country: United States
facility: Dr. Peter Merkle
state: Florida
city: Sarasota
country: United States
facility: Florida Orthopedic Foot & Ankle Center
state: Florida
city: Sarasota
country: United States
facility: James Cottom
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Syracuse
country: United States
facility: The Research Foundation of The State University of New York
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: