NCT03859609

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

February 27, 2019

Last Update Submit

August 14, 2019

Conditions

Spinal FusionAdjacent Segment Degeneration

Keywords

GAP-scoreSchwab scoreProximal Junctional FailureSpinal Fusion

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Spinal FusionPROCEDURE

Spinal alignment was evaluated according to two different score-systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • and more fusion levels

You may not qualify if:

  • Neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, University Hospital Frankfurt

Frankfurt, 60528, Germany

Location

MeSH Terms

Interventions

Spinal Fusion

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Mohammad Arab Motlagh, MD, PhD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

March 1, 2019

Primary Completion

April 30, 2019

Study Completion

June 30, 2019

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

DE(1)