Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

Cat Scan, if applicable: CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.

Study summary

This study is a multi-center, observational, prospective and retrospective data collection study

Eligibility

Primary outcome measure(s)

• Investigate radiographic outcomes — Enrollment
  The primary endpoints include the rate of fusion, and the rate of complications or reoperations. Fusion Scale:1) Radiographically evaluate the rate of fusion, as determined by a panel of independent radiologists per the below fusion assessment metrics: Lumbar fusion grading scale (Minuteman G5): 1- Definitely fused 2- Probably fused 3- Probably not fused 4- Definitely not fused; Sacroiliac fusion assessment (Liberty, Patriot): Device(s) will be evaluated for (i) the presence of bridging bone from ilium to sacrum; and (ii) any evidence of migration or loosening Additionally, if Minuteman G5 subjects have an interbody fusion device, interbody fusion will be assessed using the Bridwell scale: 1- Definite fusion 2- Probable fusion 3- Intermediate fusion/possible motion 4- Pseudoarthrosis/no bony connection

Trial sites (3)

More Spinal Simplicity LLC trials in the USA

Other trials for the same condition