AzTrials
AzTrials

KyphosisPJKNCT01441999

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

A study testing Less rigid rod and Rigid Rod in people with Kyphosis, run by Globus Medical Inc at 3 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Kyphosis
What is being tested?
Less rigid rod and Rigid Rod
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesin 2 countries
Study dates
Oct 2011to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Department of Neurosurgery, University of Michigan

    Ann Arbor, Michigan, 48109-0338

  • Peachtree Neurosurgery

    Atlanta, Georgia, 30342

Other trials in United States

Denmark1 site

  • Department of Orthopedic Surgery, University of Copenhagen, Denmark

    Copenhagen, 2100

Other trials in Denmark

About this study

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.

Read the 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.

Conditions
Kyphosis
Being tested
Less rigid rod, Rigid Rod
Keywords
Rigid rods, less rigid rods, prevent kyphosis, long constructs
Medical subject headings
Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Less rigid rodDevice

    Also called TRANSITION

    Titanium rod with semi rigid end

  • Rigid RodDevice

    Also called REVERE

    Rigid Titanium rods

Study groups in NCT01441999
Study groupRoleWhat they receive
Less rigid rodsActive comparatorTitanium rods that have a soft, plastic end
Receives: Device: Less rigid rod
Rigid RodsActive comparatorTitanium rods
Receives: Device: Rigid Rod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2016
  4. Study completionMar 2017

Why it stopped: principal investigator decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01441999
Sponsor's protocol ID
RGC11-001
Acronym
PJK
Status last verified
Jul 2019
First submitted
26 Sep 2011
Last updated
2 Aug 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16025035

  • 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.

    PubMed 17572624

  • 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.

    PubMed 18580741

  • 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.

    PubMed 16166893

  • 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.

    PubMed 18007253

  • 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.

    PubMed 10222531

  • 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.

    PubMed 12782870

  • 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.

    PubMed 18794759

  • 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.

    PubMed 20081513

  • 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.

    PubMed 20106476

  • 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.

    PubMed 16609857

  • 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.

    PubMed 438235

  • 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.

    PubMed 18774752

Questions about this trial

What is this clinical trial studying?

A study testing Less rigid rod and Rigid Rod in people with Kyphosis, run by Globus Medical Inc at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01441999, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in