NCT04645186

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

4.8 years

First QC Date

November 16, 2020

Last Update Submit

November 6, 2024

Conditions

Bone Defects

Outcome Measures

Primary Outcomes (6)

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    3 months

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    6 months

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    9 months

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    12 months

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    18 months

  • Radiological healing

    Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

    24 months

Secondary Outcomes (6)

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

    3 months

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

    6 months

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

    9 months

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

    12 months

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

    18 months

  • +1 more secondary outcomes

Study Arms (1)

Calcium Phosphate Cement (CPC)

Evaluation of CPC in long bone \& extremities

Device: bone graft substitute

Interventions

bone graft substituteDEVICE

Filling bone defects in current clinical practice

Calcium Phosphate Cement (CPC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 27, 2020

Study Start

January 5, 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)