Coflex PS3 Actual Conditions for Use Study

NCT02555280 | Recruiting FDA Device

• 1 other identifier: PS3/P110008
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 19

Brief Summary

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Conditions

Spinal Stenosis Lumbar

Keywords

moderate lumbar stenosis; neurogenic claudication; spinal stenosis; low back pain; decompression

Outcome Measures

Primary Outcomes (3)

• coflex performance compared to IDE

  Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.

  24and 60 Months

• coflex performance compared to decompression alone from ESCADA study.

  To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.

  24 Months

• Composite Clinical Success (CCS)

  * No secondary surgical interventions * No lumbar epidural injection, nerve block procedures at index level to treat spinal stenosis at any lumbar level * 15 point improvement in ODI in subjects with no interventions or injections * No new or increasing sensor or motor deficit * No major device related adverse events

  24 Month

Secondary Outcomes (7)

• Change in Oswestry Disability Index (ODI)

  Baseline, 24 and 60 months

• Change in Visual Analog Scale (VAS) for low back pain

  Baseline, 24 and 60 Months

• Change in Visual Analog Scale (VAS) for leg pain

  Baseline, 24 and 60 Months

• Neurological Status

  Baseline, 6 weeks, 12, 24, 36, 48, 60 Months

• Radiographic Assessments

  6 weeks, 12, 24, 60 Months

Other Outcomes (1)

• Safety Evaluation

  Procedure, 6 week, 12, 24, 36, 48, 60 Months

Study Arms (2)

The coflex® Interlaminar Technology

OTHER

The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.

Device: coflex® Interlaminar Technology

Decompression

ACTIVE COMPARATOR

Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.

Procedure: Decompression

Interventions

coflex® Interlaminar Technology DEVICE

Decompression plus coflex® Interlaminar Technology

Also known as: coflex

The coflex® Interlaminar Technology

Decompression PROCEDURE

Decompression alone

Decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
• Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
• Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
• Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
• Skeletally mature
• Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
• Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

You may not qualify if:

• Prior fusion or decompressive laminectomy at index lumbar level.
• Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
• Severe facet hypertrophy that requires extensive bone removal which would cause instability.
• Isthmic spondylolisthesis or spondylolysis (pars fracture).
• Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
• Osteoporsis or is at increased risk of osteoporosis.
• Back or leg pain of unknown etiology.
• Axial back pain only, with no leg, buttock, or groin pain.
• Morbid obesity defined as a body mass index \> 40.
• Known allergy to titanium, titanium alloys, or MR contrast agents.
• Active or chronic infection - systemic or local.
• Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Sponsors & Collaborators

• Xtant Medical: lead
• MCRA: collaborator

Study Sites (19)

Desert Institute for Spine Care (DISC)

Phoenix, Arizona, 85020, United States

RECRUITING

Hoag Orthopedics

Irvine, California, 92618, United States

WITHDRAWN

Sutter Health

Sacramento, California, 95816, United States

RECRUITING

Central Cost Neurological Surgery

San Luis Obispo, California, 93401, United States

RECRUITING

Cervical Disc Center of Los Angeles

Santa Monica, California, 90404, United States

RECRUITING

UC Health Spine Center

Aurora, Colorado, 80045, United States

RECRUITING

Mercy Regional Medical Center

Durango, Colorado, 81301, United States

WITHDRAWN

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

TERMINATED

01L_Northshore University Health System

Evanston, Illinois, 60201, United States

COMPLETED

24_Unity Surgical Center, LLC

Lafayette, Indiana, 47905, United States

TERMINATED

Orthopaedic Specialist of Northwest Indiana

Munster, Indiana, 46321, United States

WITHDRAWN

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

TERMINATED

St. Joseph's Medical Center

Wayne, New Jersey, 07470, United States

WITHDRAWN

Northwell Health Physician Partners Orthopaedic Institute at Great Neck

Great Neck, New York, 11021, United States

RECRUITING

Consulting Orthopaedic Associates

Toledo, Ohio, 43617, United States

WITHDRAWN

Southern Oregon Orthpaedics

Medford, Oregon, 97504, United States

RECRUITING

Summit Spine

Portland, Oregon, 97225, United States

RECRUITING

03L_Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

TERMINATED

Austin Neurosurgeons

Austin, Texas, 78746, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Interventions

Decompression

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Central Study Contacts

Laura Henderson

CONTACT

406-813-4107; lhenderson@xtantmedical.com

Isabella Rosales

CONTACT

406-924-5884; iroslaes@xtantmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 21, 2015
• Study Start: September 9, 2019
• Primary Completion: September 1, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)