N/A
Completed N=37
Custom Pack in Spine Surgery
Bone Diseases · Spine Cancer · Spine Osteoarthritis
Source: ClinicalTrials.gov NCT03050203 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Soft Tissue Dissecting Time — 38.6; 34 minues
Summary
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 .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soft Tissue Dissecting Time |
38.6; 34 | — |
| SECONDARY Surgery Time |
— | — |
| SECONDARY Postoperative Complications |
— | — |
| SECONDARY Numbers of Materials Wasted |
— | — |
| SECONDARY Blood Loss |
— | — |
| SECONDARY Pain (Score on the "Numeric Rating Scale") |
— | — |
| SECONDARY Length of Stay |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03050203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.