Retrospective Collection of Safety and Performance Data

This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Hospital Lusíadas Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All study patients will be extracted from current patient population.

Description

Inclusion Criteria:

• Patients treated with Bioceramed bone substitutes at the Center.
• Long bone & extremities: bone grafting after post-traumatic or surgically created bone defects.
• Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.

Exclusion Criteria:

Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Granules in long bone & extremities; Filling of post-traumatic or surgically created bone defects	Device: Bone graft substitute; Orthopaedic or Spine bony defects
Wedges in long bone & extremities; Osteotomies with fixation	Device: Bone graft substitute; Orthopaedic or Spine bony defects
HA paste in long bone & extremities; Filling of post-traumatic or surgically created bone defects	Device: Bone graft substitute; Orthopaedic or Spine bony defects
Granules in Spine; Spinal cage filling	Device: Bone graft substitute; Orthopaedic or Spine bony defects
HA paste in Spine; Spinal cage filling	Device: Bone graft substitute; Orthopaedic or Spine bony defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone healing, observable by x-ray/MRI	Primary endpoint will be successful radiographic bone repair.	6 months
Bone healing, observable by x-ray/MRI	Primary endpoint will be successful radiographic bone repair.	12 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.	6 - 12 months

Collaborators and Investigators

• Sponsor: Bioceramed
• Investigators: Principal Investigator: Nuno A Ribeiro, MD, Hospital Lusíadas Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020.09

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
• product manufactured in and exported from the U.S.: No