NCT02347410: SCOUT

Spineology Clinical Outcomes Trial: An IDE Investigation

Completed NA Results posted Last updated 20 October 2021

What this trial tests

NA trial testing SIFS graft containment device in Lumbar Degenerative Disc Disease in 102 participants. Completed in 4 March 2020.

Timeline

22 January 2015

Primary endpoint
22 January 2020

4 March 2020

Quick facts

Lead sponsor	Spineology, Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	22 January 2015
Primary completion	22 January 2020
Estimated completion	4 March 2020
Sites	10 locations across United States

Drugs / interventions tested

• SIFS graft containment device

Conditions studied

• Lumbar Degenerative Disc Disease — all drugs for Lumbar Degenerative Disc Disease →

Sponsor

Spineology, Inc

Who can join

Adults 21 to 80, any sex, with Lumbar Degenerative Disc Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Success Primary · 24 months

The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes: 1. Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score). 2. Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disabi

Group	Value	95% CI
SIFS Investigation Gp	71

Mean Low Back Pain Score at 24-months Post-operative Secondary · 24 months

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Group	Value	95% CI
Investigation Group	21.8	± 24.5

Mean Back Function Score at 24-months Post-operative Secondary · 24 months

A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from "0" to "100" points. A score of "0" represents "No disability" and "100" represents "Total disability". A clinically meaningful difference is defined as a 15-point reduction when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Group	Value	95% CI
Investigation Group	21.0	± 19.3

Mean Right Leg Pain Score at 24-months Post-operative Secondary · 24 months

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Group	Value	95% CI
SIFS Graft Containment Device	10.5	± 19.5

Mean Left Leg Pain Score at 24-months Post-operative Secondary · 24 Months

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Group	Value	95% CI
SIFS Graft Containment Device	13.2	± 22.6

Number of Participants With Bridging Bone Presence Secondary · 24 months

Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.

Group	Value	95% CI
SIFS Graft Containment Device	95

Number of Participants Experiencing a Device-Related Serious Adverse Event Secondary · Intra-Op through 24-month interval

Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE).

Group	Value	95% CI
Investigation Group	0

Number of Participants With a Neurological Maintenance or Improvement Secondary · 24 months

Rate of subjects that were neurologically improved or maintained compared to baseline

Group	Value	95% CI
Investigation Group	92

Number of Participants Working Secondary · 24 months

Compared the number of participants working at 24-months to number of subjects working at baseline

Group	Value	95% CI
Participants Working at Baseline	54
Participants Working at 24-Month Visit	46

Number of Participants With Narcotic Pain Medication Secondary · 24 Months

Narcotic pain medication use for back pain was compared to baseline.

Group	Value	95% CI
Investigation Group	17

Blood Loss Secondary · At the conclusion of the surgical procedure, an average of 2.6 hours

Blood loss (cc) reported for the surgical procedure.

Group	Value	95% CI
Investigation Group	137.3	± 217.4

Duration of Surgery Secondary · At the conclusion of the surgical procedure

Operative time (from incision to closure).

Group	Value	95% CI
Investigation Group	2.6	± 0.9

Adverse events — posted to ClinicalTrials.gov

Time frame: From Intraoperative through 24-months postoperative.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Investigation Group

Serious: 12/102 (12%)

Deaths: 1/102

Serious adverse events (8 terms)

Reaction	System	Investigation Group
Stenosis	Surgical and medical procedures	—
Adjacent level disease	Surgical and medical procedures	—
Dural leak	Surgical and medical procedures	—
Pulmonary thromboembolism	Respiratory, thoracic and mediastinal disorders	—
Hematoma	Surgical and medical procedures	—
Contralateral leg pain	Musculoskeletal and connective tissue disorders	—
Device improper placement	Surgical and medical procedures	—
Back and leg pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Stenosis, Adjacent level disease, Dural leak, Pulmonary thromboembolism, Hematoma, Contralateral leg pain, Device improper placement, Back and leg pain.

Data from ClinicalTrials.gov NCT02347410 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Critical Evaluation of Biomechanical Principles and Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant.
   Ferrara L, Ford W, Nunley PD, Boyan BD, et al · · 2020 · cited 2× · PMID 33122177 · DOI 10.14444/7133