CERAMENT G Device Registry

August 22, 2023 updated by: BONESUPPORT AB
This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 receive CERAMENT|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality

Description

Inclusion Criteria:

  • 18 years and over (on the day of surgery)
  • receive CERAMENT|G as a component of their treatment at a participating, contracted centre 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 form.

Exclusion Criteria:

  • Any exclusion criteria as per IFU for CERAMENT|G
  • Any off-label use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcomes
Time Frame: 12 months
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 12 months
Bone healing at final follow-up
12 months
Secondary Outcome
Time Frame: 6 and 12 months
Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted
6 and 12 months
Secondary Outcome
Time Frame: 12 months
(Recurrence of) infection/revision surgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BONESUPPORT AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 22, 2023

Primary Completion (Estimated)

September 22, 2028

Study Completion (Estimated)

September 22, 2028

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S050/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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