Calcium Phosphate Cement as Bone Void Filler

CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery

This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.

Study Overview

• Status: Recruiting
• Conditions: Bone Defects
• Intervention / Treatment: Device: bone graft substitute

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Hospital Lusiadas Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
• Give written informed consent to participate in the study and be willing to comply with the protocol requirements.
• Able to verbalize and differentiate regarding the location and intensity of pain.
• Physical and mental availability to meet the clinical and radiographic follow-up schedule.

Exclusion Criteria:

• Serious infection within two months before surgery.
• Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases.
• Primary bone tumors and contraindications in performing an X-ray or CTscan.
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Calcium Phosphate Cement (CPC); Evaluation of CPC in long bone & extremities	Device: bone graft substitute; Filling bone defects in current clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	3 months
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	6 months
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	9 months
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	12 months
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	18 months
Radiological healing	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	3 months
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	6 months
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	9 months
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	12 months
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	18 months
Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	24 months

Collaborators and Investigators

• Sponsor: Bioceramed
• Collaborators: Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (ACTUAL): November 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No