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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Globus Medical Inc

Current Primary Outcome: Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits [ Time Frame: 2 years ]

Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, sagittal balance, Sacral slope and pelvic incidence.


Original Primary Outcome: Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits [ Time Frame: 2 years ]

Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, saggital balance, Sacral slope and pelvic incidence.


Current Secondary Outcome: Patient outcome measures [ Time Frame: 2 years ]

Forms to be completed at follow up visits will include VAS, SRS 22, SF12, ODI, Patient Satisfaction, Work Status Assessment and Odom's criteria.


Original Secondary Outcome: Same as current

Information By: Globus Medical Inc

Dates:
Date Received: September 26, 2011
Date Started: October 2011
Date Completion: September 2017
Last Updated: August 9, 2016
Last Verified: August 2016