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

Primary Purpose

Kyphosis

Status

Withdrawn

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Less rigid rod

Rigid Rod

About this trial

This is an interventional prevention trial for Kyphosis focused on measuring Rigid rods, less rigid rods, prevent kyphosis, long constructs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Peachtree Neurosurgery
Department of Neurosurgery, University of Michigan
Department of Orthopedic Surgery, University of Copenhagen, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Less rigid rods

Rigid Rods

Arm Description

Titanium rods that have a soft, plastic end

Titanium rods

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01441999

First Posted

September 26, 2011

Last Updated

July 31, 2019

Sponsor

Globus Medical Inc

Collaborators

University of Michigan, Polaris Spine and Neurosurgery Center

1. Study Identification

Unique Protocol Identification Number

NCT01441999

Brief Title

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

Acronym

PJK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

principal investigator decision

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Globus Medical Inc

Collaborators

University of Michigan, Polaris Spine and Neurosurgery Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kyphosis

Keywords

Rigid rods, less rigid rods, prevent kyphosis, long constructs

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Less rigid rods

Arm Type

Active Comparator

Arm Description

Titanium rods that have a soft, plastic end

Arm Title

Rigid Rods

Arm Type

Active Comparator

Arm Description

Titanium rods

Intervention Type

Device

Intervention Name(s)

Less rigid rod

Other Intervention Name(s)

TRANSITION

Intervention Description

Titanium rod with semi rigid end

Intervention Type

Device

Intervention Name(s)

Rigid Rod

Other Intervention Name(s)

REVERE

Intervention Description

Rigid Titanium rods

Primary Outcome Measure Information:

Title

Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Patient outcome measures

Description

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan Cunningham, PhD

Organizational Affiliation

Globus Medical Inc

Official's Role

Study Director

Facility Information:

Facility Name

Peachtree Neurosurgery

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Department of Neurosurgery, University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0338

Country

United States

Facility Name

Department of Orthopedic Surgery, University of Copenhagen, Denmark

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

16025035

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. doi: 10.1097/01.brs.0000169451.76359.49.

Results Reference

background

PubMed Identifier

17572624

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. doi: 10.1097/BRS.0b013e318067dc3d.

Results Reference

background

PubMed Identifier

18580741

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.

Results Reference

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PubMed Identifier

16166893

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. doi: 10.1097/01.brs.0000179084.45839.ad.

Results Reference

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PubMed Identifier

18007253

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. doi: 10.1097/BRS.0b013e31815a7ead.

Results Reference

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PubMed Identifier

10222531

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. doi: 10.1097/00007632-199904150-00011.

Results Reference

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PubMed Identifier

12782870

Citation

Yang SH, Chen PQ. Proximal kyphosis after short posterior fusion for thoracolumbar scoliosis. Clin Orthop Relat Res. 2003 Jun;(411):152-8. doi: 10.1097/01.blo.0000069885.72909.bb.

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PubMed Identifier

18794759

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.

Results Reference

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PubMed Identifier

20081513

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.

Results Reference

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PubMed Identifier

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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.

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PubMed Identifier

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Citation

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. doi: 10.1007/s00586-006-0097-9. Epub 2006 Apr 12.

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Citation

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Citation

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

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