Infections

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Symptoms and General Pathology

Neoplasms

Musculoskeletal Diseases

Communicable Diseases

Bone Neoplasms

Bone Diseases

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022

The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality navigation system (endosight) and without.

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.

Total N° of patients: 16

PROSPECTIVE GROUP (treated WITH the guidance of endosight):

N° of patients: 8

RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):

N° of patients: 8

Main objective of the study:

Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.

N°of hospitals involved: 2.

Duration: maximum 6 months from the date of the first enrollment.

No follow-up is expected.

The study is designed to compare a prospective arm composed of 8 patients who were prescribed a CT-Guided bone biopsy (with the aid of endosight navigation system) with a retrospective arm with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 (without endosight navigation system)

all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)

Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)

Change in overall number of CT scans performed during the procedure (calculated as the total number of CT scans required to reach the target; from the 1° CT-scan (local anesthesia) to the last CT-scan (sample collection from the bone)

Distance between the tip of the needle and the center of the target (from 0mm to 10mm)

Change in the total radiant dose received by the patient (calculated by summing the radiation emitted for each CT-Scan performed from the anesthesia-point to the collection-point)

satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction)

Total number of major+minor side effects, reported during the procedure

R.A.W. - S.R.L.

Rare Diseases

Disease Attributes

Prosthetic Joint Infection

Genomic sequencing

Histological examination

Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.

Histological slides and limited sequencing data

Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection

Data may be made available as part of publication

Identification of infection and tumours using sequencing data

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy	NCT05732558	Bone Lesion Bone Tumor Bone Infection	8 Patients who ...	18 Years -	R.A.W. - S.R.L.
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection	NCT04746001	Bone Tumours Bone Infection Prosthetic Join... Prosthetic Infe...	Genomic sequenc... Histological ex...	18 Years -	Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy	NCT05732558	Bone Lesion Bone Tumor Bone Infection	8 Patients who ...	18 Years -	R.A.W. - S.R.L.
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection	NCT04746001	Bone Tumours Bone Infection Prosthetic Join... Prosthetic Infe...	Genomic sequenc... Histological ex...	18 Years -	Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Spots Global Cancer Trial Database for bone infection