NCT02575352

Brief Summary

CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
5 countries

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

6 years

First QC Date

October 12, 2015

Last Update Submit

May 24, 2018

Conditions

Bone DiseaseFracture BoneBone Cyst

Keywords

Bone SubstituteCalcium Phosphate CementGRAFTYSGRAFTYS®HBSGRAFTYS®QUICKSETBone void fillerBone growthRegistryBone defectRevision arthroplastyArthrodesis

Outcome Measures

Primary Outcomes (1)

  • Adverse Device Effect rate

    Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.

    For 24 months

Secondary Outcomes (26)

  • Technical Success rate

    At surgical procedure

  • Device Deficiencies rate

    At surgical procedure

  • Serious Adverse Events rate in the peroperative period

    At surgical procedure

  • Serious Adverse Events rate during the follow-up period

    3 months post index procedure

  • Serious Adverse Events rate during the follow-up period

    6 months post index procedure

  • +21 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients eligible and planned for bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of GRAFTYS®HBS/ GRAFTYS®Quickset.

You may qualify if:

  • Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
  • Bone defects from surgery, trauma, tumor or cyst
  • Age ≥ 18 years
  • Patient information and signed informed consent form (for data collection)
  • Affiliation to a Social Security System schema (or similar system)

You may not qualify if:

  • Patients undergoing radiotherapy or chemotherapy
  • Patients with inflammatory bone disease
  • Patients with a calcium metabolism anomaly, severe metabolic disease, vascular or neurological diseases, or immunological deficiencies
  • Bone site which can lead to the product passing into the joint cavities without appropriate controls (visual, arthroscopic, lavage…).
  • Bone site which can lead to the product passing into the meningeal spaces
  • Vertebroplasty and kyphoplasty
  • Site infected or one suspected of being so
  • A cranio-maxillofacial defect with a surface area larger than 25 cm2
  • A site exposed to the sinus (lumen) or nasal mucosa
  • Pregnant women (or likely to be) or breast-feeding women
  • Inability to understand the consent and objectives of the study
  • Unable to undergo medical monitoring for geographical, social or psychological reasons
  • Persons who are deprived of liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital La Timone

Marseille, 13385, France

RECRUITING

Unknown Facility

Marseille, France

RECRUITING

Unknown Facility

Paris, France

RECRUITING

Unknown Facility

Saint-Louis, France

RECRUITING

Unknown Facility

Kiel, Germany

RECRUITING

Unknown Facility

Ratzeburg, Germany

RECRUITING

Unknown Facility

Würzburg, Germany

RECRUITING

Unknown Facility

Palermo, Italy

RECRUITING

Unknown Facility

Piacenza, Italy

RECRUITING

Unknown Facility

Fort-de-France, Martinique

RECRUITING

Unknown Facility

Yverdon-les-Bains, Switzerland

RECRUITING

MeSH Terms

Conditions

Bone DiseasesFractures, BoneBone CystsAnkylosis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesWounds and InjuriesCystsNeoplasmsJoint Diseases

Study Officials

  • Sébastien PARRATTE, MD, Prof

    Hospital of "LA TIMONE"

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehan ALTAIFI

CONTACT

+33(0) 442 603 000mehan.altaifi@graftys.fr

Nathalie BAUDRY

CONTACT

+33(0) 442 603 009nathalie.baudry@graftys.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 14, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

FR(4)CH(1)DE(3)MA(1)IT(2)