Retrospective Collection of Safety and Performance Data

Terminated

• Conditions: Bone Defects
• Interventions: Device: Bone graft substitute

• Registration Number: NCT04644536
• Lead Sponsor: Bioceramed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-24
• Study Start: 2020-11-25
• Study First Posted: 2020-11-25
• Status Verified: 2024-11
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Granules in long bone & extremities	Bone graft substitute	Filling of post-traumatic or surgically created bone defects
HA paste in long bone & extremities	Bone graft substitute	Filling of post-traumatic or surgically created bone defects
HA paste in Spine	Bone graft substitute	Spinal cage filling
Wedges in long bone & extremities	Bone graft substitute	Osteotomies with fixation
Granules in Spine	Bone graft substitute	Spinal cage filling

Primary Outcome Measures

Name	Time	Method
Bone healing, observable by x-ray/MRI	12 months	Primary endpoint will be successful radiographic bone repair.

Secondary Outcome Measures

Name	Time	Method
Number and description of any adverse event during the follow-up	6 - 12 months	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.

Trial Locations

Locations (1)

Hospital Lusíadas Lisboa; 🇵🇹 Lisboa, Portugal