Clinical trial NCT02347410: Spineology Clinical Outcomes Trial: An IDE Investigation
Official title: Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Spineology, Inc
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Detailed description: This regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goal clinical investigation was conducted at 10 centers with 102 subjects being enrolled and treated.

Subjects were actively evaluated from pre-op to 24-months postoperative. Based on enrollment duration, some subjects were remotely assessed through self-administered surveys at 36- and/or 48-months.

The primary endpoint, assessed at 24-months postoperative, is a composite score that includes pain, function, fusion and safety assessments.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature;
* Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
* Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
* Minimum Oswestry Disability Index (ODI) score of 40;
* Received at least 6-months of conservative care; and
* Willing and able to comply with protocol evaluations and provide informed consent.

Exclusion Criteria:

* Previous fusion or total disc replacement at the index level;
* Greater than Grade I spondylolisthesis;
* Has symptomatic multi-level lumbar DDD;
* Active systemic infection or infection at the local surgical site;
* Active or suspected malignancy;
* Body Mass Index of greater than or equal to 40;
* Significant metabolic bone disease;
* Taking medication known to interfere with bone healing;
* Has a current substance abuse disorder;
* Has a somatoform, dissociative, eating or psychotic disorder;
* Waddell Signs of inorganic behavior;
* Current tobacco user;
* Is a prisoner;
* If female, pregnant or contemplating pregnancy during follow-up period; or
* Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation

Primary outcomes:
measure: Overall Success
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Mean Low Back Pain Score at 24-months Post-operative
timeFrame: 24 months
measure: Mean Back Function Score at 24-months Post-operative
timeFrame: 24 months
measure: Mean Right Leg Pain Score at 24-months Post-operative
timeFrame: 24 months
measure: Mean Left Leg Pain Score at 24-months Post-operative
timeFrame: 24 Months
measure: Number of Participants With Bridging Bone Presence
timeFrame: 24 months
measure: Number of Participants Experiencing a Device-Related Serious Adverse Event
timeFrame: Intra-Op through 24-month interval
measure: Number of Participants With a Neurological Maintenance or Improvement
timeFrame: 24 months
measure: Number of Participants Working
timeFrame: 24 months
measure: Number of Participants With Narcotic Pain Medication
timeFrame: 24 Months
measure: Blood Loss
timeFrame: At the conclusion of the surgical procedure, an average of 2.6 hours
measure: Duration of Surgery
timeFrame: At the conclusion of the surgical procedure
measure: Duration of Hospital Stay
timeFrame: From admission through discharge, an average of 2 days
measure: Patient Satisfaction
timeFrame: 24-Months
Locations:
city: DeLand
country: United States
facility: Florida Orthopaedic Associates
state: Florida
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Thibodaux
country: United States
facility: Thibodaux Regional Medical Center
state: Louisiana
city: Clinton
country: United States
facility: Georgetown University Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Peabody
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Kalamazoo
country: United States
facility: Bronson Healthcare Methodist Hospital - Neuroscience Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital - College of Medicine
state: Minnesota
city: Buffalo
country: United States
facility: University at Buffalo/SUNY
state: New York
city: South Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Retired
name: Donald Erickson, M.D.
role: STUDY_CHAIR
References: