Retrospective Collection of Safety and Performance Data

NCT04644536 | Terminated

• 1 other identifier: 2020.09
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number and description of any adverse event during the follow-up

  6 - 12 months

Study Arms (5)

Granules in long bone & extremities

Filling of post-traumatic or surgically created bone defects

Device: Bone graft substitute

Wedges in long bone & extremities

Osteotomies with fixation

Device: Bone graft substitute

HA paste in long bone & extremities

Filling of post-traumatic or surgically created bone defects

Device: Bone graft substitute

Granules in Spine

Spinal cage filling

Device: Bone graft substitute

HA paste in Spine

Spinal cage filling

Device: Bone graft substitute

Interventions

Bone graft substitute DEVICE

Orthopaedic or Spine bony defects

Granules in Spine; Granules in long bone & extremities; HA paste in Spine; HA paste in long bone & extremities; Wedges in long bone & extremities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All study patients will be extracted from current patient population.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioceramed: lead

Study Sites (1)

Hospital Lusíadas Lisboa

Lisbon, Portugal

Location

Study Officials

• Nuno A Ribeiro, MD

  Hospital Lusíadas Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 25, 2020
• Study Start: November 25, 2020
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)