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Calcium Phosphate Cement As Bone Void Filler | Clinical Trials | Clareo Health

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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

NCT04645186•Bioceramed

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital Lusíadas Lisboa

Lisbon, Portugal

Key Dates

Start Date

January 5, 2020

Primary Completion Date

November 6, 2024

Completion Date

November 6, 2024

Last Updated

November 7, 2024

Enrollment

ACTUAL participants

Conditions

Bone Defects

Interventions

bone graft substitute

DEVICE

Evaluation of the Safety and Performance of the Neocement®

NCT06973226

Bone DefectsOrthopaedic Surgery (30 Minutes or Longer)

View study

RECRUITINGNA

Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

NCT04520087

Anterior Shoulder DislocationBone Defects+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Calcium Phosphate Cement As Bone Void Filler

Inclusion Criteria

Exclusion Criteria

Evaluation of the Safety and Performance of the Neocement®

Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

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