NCT02590380

Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity

A Randomized Controlled Trial: Comparison of a Top Loading MESA® Spinal System With MESA Rail™ and a Side Locking Pedicle Screw System for the Treatment of Adolescent Paediatric Spine Deformity

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: K2M, Inc. · Industry
• Sex: All
• Age: 11 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system.

Detailed description

Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system. This is a single-center, single-surgeon randomized controlled trial with follow-up evaluations of patients conducted at initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure. Adverse events will be monitored continuously.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	MESA Rail Deformity System	The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.
DEVICE	DePuy Synthes USS II System	The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.

Timeline

• Start date: 2022-09-01
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2015-10-29
• Last updated: 2021-10-21

Locations

1 site across 1 country: United Kingdom