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

Johns Hopkins University

Status: Completed

Conditions: Scoliosis; Kyphosis

Treatments: Procedure: Traditional technique; Procedure: Minimally invasive technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00890227

NA_00002729

SORC_KMK_08_006 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Traditional technique

Active Comparator group

Description:

All level open instrumented posterior spinal fusions

Treatment:

Procedure: Traditional technique

Minimally invasive technique

Active Comparator group

Description:

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

Treatment:

Procedure: Minimally invasive technique