Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection (PJK)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection|
- Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Forms to be completed at follow up visits will include VAS, SRS 22, SF12, ODI, Patient Satisfaction, Work Status Assessment and Odom's criteria.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441999
|Contact: Bryan Cunningham, PhD||610-930-1800 ext 2533|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Thomas Morrison, MD 404-256-2633 firstname.lastname@example.org|
|Principal Investigator: Thomas Morrison, MD|
|United States, Michigan|
|Department of Neurosurgery, University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109-0338|
|Contact: Frank LaMarca, MD 734-936-5024 email@example.com|
|Principal Investigator: Frank LaMarca, MD|
|Department of Orthopedic Surgery, University of Copenhagen, Denmark||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Benny Dahl, MD 45 40465555 firstname.lastname@example.org|
|Principal Investigator: Benny Dahl, MD|
|Study Director:||Bryan Cunningham, PhD||Globus Medical Inc|