OLIF25™ /OLIF51™ Study

A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02657421

Enrollment

168

Registered

2016-01-15

Start date

2015-11-30

Completion date

2018-05-03

Last updated

2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Scoliosis

Brief summary

The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.

Interventions

PROCEDUREOblique Lateral Interbody Fusion

The oblique lateral interbody fusion (OLIF) procedures at L2-L5 (OLIF25™) and L5-S1 (OLIF51™) is a minimally invasive surgical option for degenerative lumbar disease. This approach allows for psoas-preserving access to the lumbar spine and minimizes the need to reposition the patient during surgery for accessing additional spinal levels for the interbody fusion portion of the procedure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is 18 years of age or older. 2. Patient agrees to participate in the study and is able to sign the informed consent/data release form. 3. Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.

Exclusion criteria

1\. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).

Design outcomes

Primary

Measure	Time frame	Description
Rate of adverse events	24 months	—
Oswestry Disability Index (ODI)	24 months	—
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire	24 months	—
Neurological deficits assessed by neurological status	24 months	Neurological status is based on seven components of measurements: Motor function; Sensory function; Deep Tendon reflexes; Sympathetic Exam; Claudication; Urinary bladder retention/Bowel retention; and Sexual Dysfunction.
Back and Leg Pain Measured by Visual Analogue Scales (VAS)	24 months	—

Other

Measure	Time frame	Description
Work status	24 months	—
Spino-Pelvic Measurements by X-ray	24 months	—
Surgical Data	Day 0 to Day 5	Surgical data include mean blood loss, operative time, and length of hospital stay (LOS).

Countries

Belgium, Czechia, France, Italy, Portugal, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026