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

Kyphosis Clinical Trial

— PJK  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01441999
• Other study ID #: RGC11-001
• Status: Withdrawn
• Phase: N/A
• Start date: October 2011
• Est. completion date: March 2017

Study information

• Verified date: July 2019
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult patients with degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis) requiring treatment with an instrumented posterior fusion from the thoracolumbar junction (T10-L1) to the sacrum

• At least 18 years of age and maximum 70 years of age

• Ability to provide Informed Consent for study participation and patients to return for all follow-up visits

Exclusion Criteria:

• Presence of systemic or localized infection

• Previous fusion attempt at the involved level(s)

• More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s)

• Trauma at the levels to be fused

• Previous documentation of osteopenia or osteomalacia

• Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing

• Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)

• Immunosuppressive disorder

• Pregnancy

• History of alcohol and/or drug abuse

• Any known allergy to a metal alloy

• Mentally incompetent or prisoner

• Currently a participant in another study

• Preoperative structural deformity in the thoracic spine (kyphosis >60 degrees, Coronal curve >40 degrees)

• Circumferential fusion above L1

Related Conditions & MeSH terms

• Kyphosis

Intervention

Device:
• Less rigid rod
Titanium rod with semi rigid end
• Rigid Rod
Rigid Titanium rods

Locations

Country	Name	City	State
Denmark	Department of Orthopedic Surgery, University of Copenhagen, Denmark	Copenhagen
United States	Department of Neurosurgery, University of Michigan	Ann Arbor	Michigan
United States	Peachtree Neurosurgery	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Globus Medical Inc	Polaris Spine and Neurosurgery Center, University of Michigan

Countries where clinical trial is conducted

United States,  Denmark, 

References & Publications (13)

Bunge EM, Juttmann RE, de Kleuver M, van Biezen FC, de Koning HJ; NESCIO group. Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment. Eur Spine J. 2007 Jan;16(1):83-9. Epub 2006 Apr 12. — View Citation

Glassman SD, Schwab F, Bridwell KH, Shaffrey C, Horton W, Hu S. Do 1-year outcomes predict 2-year outcomes for adult deformity surgery? Spine J. 2009 Apr;9(4):317-22. doi: 10.1016/j.spinee.2008.06.450. Epub 2008 Sep 6. — View Citation

Glattes RC, Bridwell KH, Lenke LG, Kim YJ, Rinella A, Edwards C 2nd. Proximal junctional kyphosis in adult spinal deformity following long instrumented posterior spinal fusion: incidence, outcomes, and risk factor analysis. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1643-9. — View Citation

Hee HT, Yu ZR, Wong HK. Comparison of segmental pedicle screw instrumentation versus anterior instrumentation in adolescent idiopathic thoracolumbar and lumbar scoliosis. Spine (Phila Pa 1976). 2007 Jun 15;32(14):1533-42. — View Citation

Helgeson MD, Shah SA, Newton PO, Clements DH 3rd, Betz RR, Marks MC, Bastrom T; Harms Study Group. Evaluation of proximal junctional kyphosis in adolescent idiopathic scoliosis following pedicle screw, hook, or hybrid instrumentation. Spine (Phila Pa 1976). 2010 Jan 15;35(2):177-81. doi: 10.1097/BRS.0b013e3181c77f8c. — View Citation

Hollenbeck SM, Glattes RC, Asher MA, Lai SM, Burton DC. The prevalence of increased proximal junctional flexion following posterior instrumentation and arthrodesis for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2008 Jul 1;33(15):1675-81. doi: 10.1097/BRS.0b013e31817b5bea. — View Citation

Kim YJ, Bridwell KH, Lenke LG, Glattes CR, Rhim S, Cheh G. Proximal junctional kyphosis in adult spinal deformity after segmental posterior spinal instrumentation and fusion: minimum five-year follow-up. Spine (Phila Pa 1976). 2008 Sep 15;33(20):2179-84. doi: 10.1097/BRS.0b013e31817c0428. — View Citation

Kim YJ, Bridwell KH, Lenke LG, Kim J, Cho SK. Proximal junctional kyphosis in adolescent idiopathic scoliosis following segmental posterior spinal instrumentation and fusion: minimum 5-year follow-up. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2045-50. — View Citation

Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. — View Citation

Lee GA, Betz RR, Clements DH 3rd, Huss GK. Proximal kyphosis after posterior spinal fusion in patients with idiopathic scoliosis. Spine (Phila Pa 1976). 1999 Apr 15;24(8):795-9. — View Citation

Taylor TC, Wenger DR, Stephen J, Gillespie R, Bobechko WP. Surgical management of thoracic kyphosis in adolescents. J Bone Joint Surg Am. 1979 Jun;61(4):496-503. — View Citation

Wang J, Zhao Y, Shen B, Wang C, Li M. Risk factor analysis of proximal junctional kyphosis after posterior fusion in patients with idiopathic scoliosis. Injury. 2010 Apr;41(4):415-20. doi: 10.1016/j.injury.2010.01.001. Epub 2010 Jan 27. — View Citation

Yang SH, Chen PQ. Proximal kyphosis after short posterior fusion for thoracolumbar scoliosis. Clin Orthop Relat Res. 2003 Jun;(411):152-8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits	Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, sagittal balance, Sacral slope and pelvic incidence.	2 years
Secondary	Patient outcome measures	Forms to be completed at follow up visits will include VAS, SRS 22, SF12, ODI, Patient Satisfaction, Work Status Assessment and Odom's criteria.	2 years