N/A
Completed N=400
InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
Spine Fusion
Source: ClinicalTrials.gov NCT02280187 ↗
Enrolled (actual)
400
Serious AEs
6.8%
Results posted
Feb 2017
Primary outcomePrimary: The Primary Diagnostic Indication for InductOs Use — 32.3; 4.5; 3.5; 29.8 percentage of participants
Summary
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.
The aim of the study is to describe the real world use of InductOs in Spine fusion in France.
Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Diagnostic Indication for InductOs Use |
32.3; 4.5; 3.5; 29.8; 0.8; 14.8 | — |
| PRIMARY Spine Levels Treated |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Primary Surgical Approaches Used for Implantation of InductOs |
188; 111; 4; 106; 221; 4 | — |
| PRIMARY The Interbody Device Brand/Generic Names Used With InductOs |
26; 3; 2; 91; 4; 43 | — |
| PRIMARY Placement of the Matrix Wetted With InductOs |
270; 335; 60; 22; 20 | — |
| PRIMARY Supplemental Fixation |
200; 399; 99 | — |
| PRIMARY Instrumentations Used for Stabilization |
454; 394; 105; 77 | — |
| SECONDARY The Number of Adverse Events of Interest |
31 | — |
| SECONDARY AEI Categorisation |
0; 1; 3; 1; 5; 7 | — |
| SECONDARY The Number of Subjects Having Secondary Spine Surgical Intervention |
3; 9 | — |
| SECONDARY The Number of Unplanned Secondary Spine Interventions in Subgroups |
2; 1; 0; 3 | — |
| SECONDARY Fusion Status at the Last Assessment Performed by 12 Months |
73.3; 26.7 | — |
| SECONDARY Fusion Rates in Subgroups |
72.7; 74.3; 78.6; 73.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
- Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
- Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
- Patient is ≥18 years old at the date of the Study Procedure
Exclusion Criteria
- Patient declines participation
- Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
- Patient died since study procedure*
- Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
Data sourced from ClinicalTrials.gov (NCT02280187). 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.