Comparison of GAP-score With Schwab-score | NCT03859609

Studies
Comparison of GAP-score With Schwab-score

NCT03859609

Sponsor

Mohammad ARAB MOTLAGH

Status

Completed

Last Update Posted

Aug 16, 2019Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Spinal Fusion
Adjacent Segment Degeneration

Interventions

Spinal Fusion

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Feb 27, 2019

First Submission Date that Met QC Criteria

Feb 28, 2019

First Posted Date

Mar 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2019

Last Update Posted Date

Aug 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal Fusion	Procedure	Spinal alignment was evaluated according to two different score-systems

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3 and more fusion levels

Exclusion Criteria:

Neuromuscular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who had fusion operation with dorsal instrumentation on at least 3 spinal levels

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Arab Motlagh, MD, PhD	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedic Surgery, University Hospital Frankfurt		Frankfurt		60528	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D013123	Spinal Fusion

Ancestor Terms

ID	Term
D001174	Arthrodesis
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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