The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.

NCT ID: NCT04154202

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-11-15

Brief Summary

This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening.

The proposed study will be presented to the ethical committee of the medical center and will be started once approved.

Conditions

Bone Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bone inaction patients

Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.

Group Type: EXPERIMENTAL

Bone Scan

Intervention Type: OTHER

Bone Scan: three-phase planar Bone Scan and a SPECT/CT \[perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan\].

Interventions

Bone Scan

Bone Scan: three-phase planar Bone Scan and a SPECT/CT \[perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan\].

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.

Exclusion Criteria

1. Patients younger than 18 years;

2. Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (<3 months) fractures around the prosthesis;

3. Pathological fractures (e.g. Metastatic).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TASMC-19-ES-0468-CTIL

Identifier Type: -

Identifier Source: org_study_id