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NCT Number: NCT06156904

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.

All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.

It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

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Key information

Conditions

Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
  • Male or female patient ≥ 18 years old.
  • Patients willing and able to attend the standard of care follow-up visits and procedures.
  • Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.

Exclusion criteria

  • Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
  • Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
  • Woman who is pregnant or breast-feeding.
  • Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.

Treatment and study plan

Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.

Device

All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities.

b.Bone is a bone substitute without initial mechanical properties, therefore it is to be used in conjunction with internal/external fixation devices suitable for primary stabilization.

Primary outcomes

  1. Performance of b.Bone by determining the radiographic healing/union after surgery.

    Time frame: 12 months

    Number and rate of patients with successful bone healing/union observable by X-ray or CT scan.

    Radiologic images will be evaluated by the surgeon according to the modified radiographic Union Scale for Tibial fractures (mRUST) classification or the modified Neer classification when applicable.

Secondary outcomes

  1. Clinical outcomes measured by patient-reported outcomes - Pain

    Time frame: Baseline and 3, 6 and 12 months

    Change in the patient-reported pain using the Visual Analoge Scale from baseline to month 3, month 6 and month 12 post-treatment.

    Patient-completed questionnaire scoring pain by using 10 cm line. Zero (0) indicates no pain at all and ten (10) the worst pain ever.

  2. Clinical outcomes measured by patient-reported outcomes - Quality of Life

    Time frame: Baseline and 3, 6 and 12 months

    Change in the patient-reported Quality of Life assessed by Health Questionnaire from baseline to month 3, month 6 and month 12 post-treatment.

  3. Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE

    Time frame: Up to 24 months

    Number and rate of procedure and device-related adverse events (AEs) and Serious adverse events (SAEs) during the clinical investigation period.

  4. Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions

    Time frame: Up to 24 months

    Rate of reinterventions related to the treatment applied during the clinical investigation

Other outcomes

  1. Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - bone formation

    Time frame: Up to 24 months

    Change of bone formation observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.

  2. Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - remodelling

    Time frame: Up to 24 months

    Change of remodelling observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.

  3. Exploratory outcomes: Evaluate the evolution over time of complementary radiographic parameter - material resorption

    Time frame: Up to 24 months

    Change of material resorption observable by X-ray/CT scan from the first evaluation immediately after b.Bone implantation through the observational period until the last available X-ray/CT scan.

  4. Exploratory outcomes: Evaluate the performance of b.Bone on different anatomical sites of implantation.

    Time frame: Baseline and 3, 6 ,12, 24 months

    b.Bone performance on different subsets of patients depending on the anatomical site of implantation:

    • subset a: pelvis
    • subset b: upper extremities
    • subset c: lower extremities

    (The performance will be assessed as defined for the primary and secondary outcomes)

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Granados, MSc

CONTACT

[email protected]

+393450954463

Susanna Salvagno

CONTACT

[email protected]

+393497337442

Sponsors and collaborators

Lead sponsor

GreenBone Ortho S.p.A.

Industry

Registry information

Official study title

A Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.

Acronym: OSsIRIS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.