OLIF25™ /OLIF51™ Study

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02657421
• Other study ID #: P15-05
• Status: Terminated
• Start date: November 2015
• Est. completion date: May 3, 2018

Study information

• Verified date: July 2017
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Scoliosis

Intervention

Procedure:
• Oblique 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

Locations

Country	Name	City	State
Belgium	Ste Elisabeth hospital	Brussels
Czechia	FN Ostrava	Ostrava	Poruba
France	Clinique Du Mail	La Rochelle
Italy	Azienda Ospedaliera - Ospedale Civile di Legnano	Legnano
Portugal	CUF Descobertas	Lisbon
Puerto Rico	Orthospine Group	San Juan
United States	The B.A.C.K. Center	Melbourne	Florida
United States	Advanced Neurosurgery Associates	Murrieta	California
United States	NewYork-Presbyterian/The Allen Hospital	New York	New York
United States	Alleghany Health Network Research Institute	Pittsburgh	Pennsylvania
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	Foundation for Orthopaedic Research and Education (FORE)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical Data	Surgical data include mean blood loss, operative time, and length of hospital stay (LOS).	Day 0 to Day 5
Other	Work status		24 months
Other	Spino-Pelvic Measurements by X-ray		24 months
Primary	Back and Leg Pain Measured by Visual Analogue Scales (VAS)		24 months
Primary	Oswestry Disability Index (ODI)		24 months
Primary	European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire		24 months
Primary	Neurological deficits assessed by neurological status	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.	24 months
Primary	Rate of adverse events		24 months