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

NCT04154202 | Unknown

• 1 other identifier: TASMC-19-ES-0468-CTIL
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bone inaction patients

EXPERIMENTAL

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

Interventions

Bone Scan OTHER

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

Bone inaction patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Patients younger than 18 years;
• Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (\<3 months) fractures around the prosthesis;
• Pathological fractures (e.g. Metastatic).

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 6, 2019
• Study Start: November 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: November 15, 2021
• Last Updated: November 6, 2019

Record last verified: 2019-11