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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Bone Infection

Treatments: Other: Bone Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04154202

TASMC-19-ES-0468-CTIL

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Bone inaction patients

Experimental group

Description:

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.

Treatment:

Other: Bone Scan