CERAMENT™| Bone Void Filler Device Registry

Sponsor

BONESUPPORT AB (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04244942

Collaborator

(none)

300

Enrollment

Locations

Anticipated Duration (Months)

42.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Device: CERAMENT BVF

Detailed Description

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

CERAMENT™| Bone Void Filler Device Registry

Actual Study Start Date :

Mar 30, 2020

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

Mar 30, 2025

Outcome Measures

Primary Outcome Measures

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 24 months [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 24 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 24 months [24 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 24 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 24 months [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 24 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 24 months [24 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 24 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 24 months [12 and 24 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 24 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 24 months [12 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 24 months
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 24 months [24 months]
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 24 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 24 months [12 months]
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 24 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 24 months [24 months]
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 24 months

Secondary Outcome Measures

Radiological assessment at 6 and 12 months. Objective assessment of regeneration [6 Months]
Bone healing
Radiological assessment at 6 and 12 months. Objective assessment of regeneration [12 Months]
Bone healing
Pain VAS score [6, 12, and 24 Months]
Pain assessment at 6,12, and 24 months
EQ-5D-3L [6, 12, and 24 months]
Functional assessment at 6, 12, and 24 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth	Scottsdale	Arizona	United States	85258
2	Indiana University	Indianapolis	Indiana	United States	46202
3	OrthoIndy	Indianapolis	Indiana	United States	46278
4	University of Kentucky	Lexington	Kentucky	United States	40536
5	The Research Foundation of The State University of New York	Syracuse	New York	United States	13210
6	OrthoCarolina	Charlotte	North Carolina	United States	28207
7	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

BONESUPPORT AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BONESUPPORT AB

ClinicalTrials.gov Identifier:

NCT04244942

Other Study ID Numbers:

S025/2018

First Posted:

Jan 28, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Musculoskeletal Diseases

Study Results

No Results Posted as of Mar 15, 2022