NCT04308018

Brief Summary

To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Status
unknown

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

November 21, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

November 21, 2019

Last Update Submit

March 11, 2020

Conditions

Degeneration Spine

Outcome Measures

Primary Outcomes (1)

  • Revision rate

    Revisions rates between groups 1 year after surgery

    1 year after surgery

Secondary Outcomes (15)

  • Inter-group Oswestry disability index (ODI)

    3, 6, 12, and 24 months after surgery

  • British Medical Research Council (BMRC) scale

    3, 6, 12, and 24 months after surgery

  • Severe adverse events

    3, 6, 12, and 24 months after surgery

  • Back pain intensity

    3, 6, 12, and 24 months after surgery

  • Health-related quality of life

    3, 6, 12, and 24 months after surgery

  • +10 more secondary outcomes

Study Arms (2)

S1

ACTIVE COMPARATOR

Caudal end of the instrumentation at S1

Procedure: S1 screws

S2alar-iliac

ACTIVE COMPARATOR

Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

Procedure: S2alar-iliac screws

Interventions

S2alar-iliac screwsPROCEDURE

Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

S2alar-iliac
S1 screwsPROCEDURE

Caudal end of the instrumentation at S1

S1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
  • Lumbar or thoracolumbar Instrumentation
  • Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
  • Age ≥ 18 years

You may not qualify if:

  • Scoliosis \>20°
  • Chronic steroid usage
  • Significant co-morbidity influencing the surgical success:
  • Osteoporosis
  • Rheumatoid arthritis
  • Mental illness/dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sandro Krieg, MD

    Technical University Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro Krieg, MD

CONTACT

8941402151sandro.krieg@tum.de

Sebastian Ille, MD

CONTACT

8941402151sebastian.ille@tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2019

First Posted

March 13, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2023

Last Updated

March 13, 2020

Record last verified: 2020-03