Custom Pack in Spine Surgery (kit)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Spine Osteoarthritis; Bone Diseases; Spine Cancer

Treatments: Other: custom pack; Other: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03050203

0033168

Details and patient eligibility

About

Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Degenerative spinal disease from 2 to 4 levels,
• Oncologic spine disease with only decompression and stabilization.

Exclusion criteria

• Revision surgeries,
• Minimally invasive interventions,
• Interventions that provide a dual access, and
• Patients who refuse consent to experimentation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

custom pack

Experimental group

Treatment:

Other: custom pack

standard care

Active Comparator group

Treatment:

Other: standard care