Comparison of GAP-score With Schwab-score

Spinal Fusion Clinical Trial

Official title:

Failure Prediction of Adult Spinal Deformity Surgery Comparing GAP-score With Schwab-score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859609
• Other study ID #: Adult Spinal Deformity Surgery
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 3 and more fusion levels

Exclusion Criteria:

• Neuromuscular disease

Related Conditions & MeSH terms

• Adjacent Segment Degeneration
• Spinal Fusion

Intervention

Procedure:
• Spinal Fusion
Spinal alignment was evaluated according to two different score-systems

Locations

Country	Name	City	State
Germany	Department of Orthopaedic Surgery, University Hospital Frankfurt	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad ARAB MOTLAGH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological Evaluation	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	2 months