NCT01441999

Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The treatment of adult deformity has improved with the development and use of modern segmental instrumentation, including posterior instrumentation. However, the incidence of proximal junctional kyphosis (PJK) caused by the accelerated degeneration of the joint capsules and smaller articular processes in the proximal junctional region has also been noted. One potential way of decreasing PJK is to decrease the structural rigidity of the construct at the top thereby providing a transition to the non-instrumented spine and allowing for less facet capsule and muscle disruption.

Detailed description

While a possible solution to PJK is to reduce structural rigidity at the top of the construct, there is a need to investigate it. In the proposed study, the investigators will compare the rate of proximal junctional kyphosis in patients treated with a stainless steel rod (REVERE Stabilization System) versus those treated with TRANSITION Stabilization System. Patient outcome measures (Scoliosis Research Society (SRS-22), SF12 and ODI) and radiographic measurements (including lumbar lordosis (L1-S1), adjacent segment kyphosis, thoracolumbar kyphosis (T10-L2), sagittal balance, sacral slope, and pelvic incidence) will be analyzed.

Conditions

• Kyphosis

Interventions

Type	Name	Description
DEVICE	Less rigid rod	Titanium rod with semi rigid end
DEVICE	Rigid Rod	Rigid Titanium rods

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2011-09-28
• Last updated: 2019-08-02

Locations

3 sites across 2 countries: United States, Denmark