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Comparison of GAP-score With Schwab-score

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ClinicalTrials.gov Identifier: NCT03859609
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital

Study Description
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Brief Summary:
The predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation.

Condition or disease Intervention/treatment
Spinal Fusion Adjacent Segment Degeneration Procedure: Spinal Fusion

Detailed Description:
The multilevel spinal fusion is associated with high rate of failure. This results from insufficient adaptation of the fused spine to the proper individual spinal alignment. In the recent years, comprehensive understanding of spinal alignment and definition of several parameters contributed to develop score systems to evaluate the alignment of the multilevel spinal fusion and to predict failure. In the following study the results of multilevel spinal fusion were evaluated retrospectively according to two scoring systems: GAP-score und Schwab-score. The predictive value of each score system is analyzed by the correlation of the failure rate with its corresponding score value.
Study Design
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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Failure Prediction of Adult Spinal Deformity Surgery Comparing GAP-score With Schwab-score
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : June 30, 2019
Groups and Cohorts
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Intervention Details:
  • Procedure: Spinal Fusion
    Spinal alignment was evaluated according to two different score-systems

Outcome Measures
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Primary Outcome Measures :
  1. Radiological Evaluation [ Time Frame: 2 months ]
    Pelvic tilt in degree, Pelvic incidence in degree, Sacral slope in degree, Lumbar lordosis in degree, L5-S1 lordosis in degree, Thoracic kyphosis in degree, Sagittal vertical axis in degree, Thoracolumbar kyphosis in degree, Global tilt in degree, Cobb angle in degree


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had fusion operation with dorsal instrumentation on at least 3 spinal levels
Criteria

Inclusion Criteria:

  • 3 and more fusion levels

Exclusion Criteria:

  • Neuromuscular disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859609


Locations
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Germany
Department of Orthopaedic Surgery, University Hospital Frankfurt
Frankfurt, Germany, 60528
Sponsors and Collaborators
Mohammad ARAB MOTLAGH
Investigators
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Principal Investigator: Mohammad Arab Motlagh, MD, PhD University Hospital, Frankfurt
More Information
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Responsible Party: Mohammad ARAB MOTLAGH, MD, PhD, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03859609    
Other Study ID Numbers: Adult Spinal Deformity Surgery
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital:
GAP-score
Schwab score
Proximal Junctional Failure
Spinal Fusion