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

Bone Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04154202
• Other study ID #: TASMC-19-ES-0468-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2019
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 15, 2021
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bone Infection

Intervention

Other:
• 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].

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..		1 year