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NCT Number: NCT00890227

Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels

This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.

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Key information

Conditions

Scoliosis Bone Diseases Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

About this study

Currently, there are two different surgical methods used in the treatment of these problems. One method includes an all open posterior spinal fusion (large incision with opening of the muscles); this is also known as a traditional technique. The second method involves an open surgery for the portion of the spine requiring a fusion except the very top area, where minimally invasive technique (smaller incision and without opening of the muscles) is used.

One possible side effect of either method for surgical repair is a condition called proximal junctional kyphosis (PJK). PJK occurs in the form of fracture at the top vertebra involved in the surgery or as a loss of correction of spinal alignment achieved, through gradual bending forward of the spine over time. In this study we want to compare the rate of PJK between two groups of patients undergoing long posterior spinal instrumentation fusion.

People undergoing long posterior spinal instrumented fusion may join.

About 68 people will join.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals presenting for surgical correction of scoliosis and/or kyphosis of the thoracolumbar spine are the primary target for enrollment.
  • Men and women ages 18 years or older will be eligible for participation in the current study.
  • In addition, individuals must be able to provide informed consent (Mini-Mental State Examination score of at least 18/30).

Treatment and study plan

Traditional technique

Procedure

All level open instrumented posterior spinal fusions

Minimally invasive technique

Procedure

Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Primary outcomes

  1. To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.

    Time frame: 12 months

    rate of proximal junctional fracture or instrumentation failure

Secondary outcomes

  1. To evaluate complication rate between the two groups.

    Time frame: 3 months

    rate of complications

  2. To compare the total operative time between the two groups of surgical patients (as stratified above).

    Time frame: 12 months

    operative time

  3. To compare the length of hospital stay between the two groups of surgical patients (as stratified above).

    Time frame: 12 months

    length of hospital stay

  4. To compare the total recovery time between the two groups of surgical patients (as stratified above).

    Time frame: 12 months

    total recovery time

  5. To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).

    Time frame: 12 months

    pain rating

  6. To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).

    Time frame: 12 months

    oswestry disability index

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels/Levels

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2009
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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