Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection (PJK)
|ClinicalTrials.gov Identifier: NCT01441999|
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : February 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Kyphosis||Device: Less rigid rod Device: Rigid Rod||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection|
|Study Start Date :||October 2011|
|Primary Completion Date :||December 2016|
|Study Completion Date :||March 2017|
Active Comparator: Less rigid rods
Titanium rods that have a soft, plastic end
Device: Less rigid rod
Titanium rod with semi rigid end
Other Name: TRANSITION
Active Comparator: Rigid Rods
Device: Rigid Rod
Rigid Titanium rods
Other Name: REVERE
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441999
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Michigan|
|Department of Neurosurgery, University of Michigan|
|Ann Arbor, Michigan, United States, 48109-0338|
|Department of Orthopedic Surgery, University of Copenhagen, Denmark|
|Copenhagen, Denmark, 2100|
|Study Director:||Bryan Cunningham, PhD||Globus Medical Inc|