The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
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|ClinicalTrials.gov Identifier: NCT04154202|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Infection||Other: Bone Scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||November 15, 2021|
Experimental: 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.
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].
- 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.. [ Time Frame: 1 year ]