Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects

NCT05676905 | Terminated

• 1 other identifier: TBMED1.1
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.

Conditions

Bone Deformity

Keywords

Bone cement; Observational study; Real-world study

Outcome Measures

Primary Outcomes (1)

• Bone consolidation (Neer/ RUST classification)

  Neer classification is used for trabecular bone: Healed: Cyst filled by new bone, with or without small radiolucent area(s) \< 1 cm in size Healing with defects: Radiolucent area(s) \< 50% of the diameter of bone, with enough cortical thickness to prevent fracture Persistent cyst: Radiolucent area \> 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size) RUST is classified according to the scores: Score 1: Fracture Line, No Callus Score 2: Fracture Line, Visible Callus Score 3: Fracture Line, Bridging Callus Score 4: No fracture line, remodelled

  24 months

Secondary Outcomes (1)

• Functional scores

  24 months

Other Outcomes (3)

• Adverse events

  24 months

• Quality of life measured through the SF-36 Questionnaire

  24 months

• Technical success rate

  24 months

Interventions

Neocement DEVICE

Bone graft substitutes

Also known as: Neocement Inject P

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

Bone graft substitute patients who underwent surgery with Neocement and meet the eligibility criteria.

You may qualify if:

• Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.
• Age ≥ 18 years of both genders (male and female)
• Patient signed informed consent form (for data collection)
• Bone defects surgically created or osseous defects created from traumatic injury to the bone
• Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized

You may not qualify if:

• Acute or chronic infection at the surgical site;
• Metabolic bone diseases;
• Severe degenerative disease conditions in which general bone grafting is not advisable;
• Active malignancy.
• Inability to understand consent and objectives of the study;
• Pregnant women or breastfeeding women;
• Unable to undergo medical monitoring for geographical, social or psychological reasons.

Sponsors & Collaborators

• Bioceramed: lead
• European Clinical Research Infrastructure Network: collaborator
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Centro Hospitalar Universitário de Lisboa Central

Lisbon, Lisbon District, Portugal

Location

Study Officials

• Nuno Ribeiro, M. Doctor

  Hospital Lusíadas Lisboa

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: January 9, 2023
• Study Start: November 6, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: January 31, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)