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Completed

NCT Number: NCT02347410

Spineology Clinical Outcomes Trial: An IDE Investigation

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.

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Key information

Conditions

Lumbar Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Orthopaedic Associates, DeLand, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SIFS graft containment device

Device

The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.

Other names: SIFS mesh

Primary outcomes

  1. Overall Success

    Time frame: 24 months

    The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes:

    • 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).
    • 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 Disability Index (ODI) score minus the post-op ODI score).
    • Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan
    • Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint.

    For the study to be a success, 68% of subjects need to meet the above success criteria.

Other outcomes

  1. Mean Low Back Pain Score at 24-months Post-operative

    Time frame: 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.

  2. Mean Back Function Score at 24-months Post-operative

    Time frame: 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.

  3. Mean Right Leg Pain Score at 24-months Post-operative

    Time frame: 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.

  4. Mean Left Leg Pain Score at 24-months Post-operative

    Time frame: 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.

  5. Number of Participants With Bridging Bone Presence

    Time frame: 24 months

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

  6. Number of Participants Experiencing a Device-Related Serious Adverse Event

    Time frame: 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).

  7. Number of Participants With a Neurological Maintenance or Improvement

    Time frame: 24 months

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

  8. Number of Participants Working

    Time frame: 24 months

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

  9. Number of Participants With Narcotic Pain Medication

    Time frame: 24 Months

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

  10. Blood Loss

    Time frame: At the conclusion of the surgical procedure, an average of 2.6 hours

    Blood loss (cc) reported for the surgical procedure.

  11. Duration of Surgery

    Time frame: At the conclusion of the surgical procedure

    Operative time (from incision to closure).

  12. Duration of Hospital Stay

    Time frame: From admission through discharge, an average of 2 days

    Number of days subject was in the hospital (from admission to discharge).

  13. Patient Satisfaction

    Time frame: 24-Months

    Subjects rating their procedure as excellent or good

Sponsors and collaborators

Lead sponsor

Spineology, Inc

Industry

Registry information

Official study title

Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

Acronym: SCOUT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2015
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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