Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions

ConditionSpinal Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorAO Foundation, AO Spine

About this trial

This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 45 years and older.

Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).

Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.

Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.

Disqualifiers

Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).

Spinal fusion performed for tumor.

Spinal fusion performed for infection.

Patients with Parkinson's Disease.

Trial population

Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • long-segment posterior TL instrumented fusion

    Procedure/Surgery

    long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.

Treatment groups

1,244 Participants
are divided into 2 treatment groups
Group A: primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs1 intervention
Group B: primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs1 intervention

Trial outcomes

Primary outcomes

1

Rod fracture (RF)

Incidence of rod fracture(s)

Time frame
2 years

Secondary outcomes

1

Time to rod fracture

Time to the first rod fracture after index surgery

Time frame
2 years
2

Time to rod fracture

Time to the first rod fracture after index surgery

Time frame
10 years and 3 months
3

Configurations of supplementary rod constructs

Descriptions of configurations of supplementary rod constructs

Time frame
Baseline
4

Treatment for rod fracture

Descriptions of different treatment strategies for rod fractures

Time frame
10 years and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.