Coflex PS3 Actual Conditions for Use Study

Spinal Stenosis Lumbar Clinical Trial

— PAS003  

Official title:

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 for Use Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02555280
• Other study ID #: PS3/P110008
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: November 2027

Study information

• Verified date: January 2024
• Source: Xtant Medical
• Contact: Laura Henderson
• Phone: 406-813-4107
• Email: lhenderson[@]xtantmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2027
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.

2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.

3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.

4. 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.

5. Skeletally mature

6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).

7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.

8. 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.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at index lumbar level.

2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).

3. Severe facet hypertrophy that requires extensive bone removal which would cause instability.

4. Isthmic spondylolisthesis or spondylolysis (pars fracture).

5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).

6. Osteoporsis or is at increased risk of osteoporosis.

7. Back or leg pain of unknown etiology.

8. Axial back pain only, with no leg, buttock, or groin pain.

9. Morbid obesity defined as a body mass index > 40.

10. Known allergy to titanium, titanium alloys, or MR contrast agents.

11. Active or chronic infection - systemic or local.

12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Device:
• coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology

Procedure:
• Decompression
Decompression alone

Locations

Country	Name	City	State
United States	UC Health Spine Center	Aurora	Colorado
United States	Austin Neurosurgeons	Austin	Texas
United States	Mercy Regional Medical Center	Durango	Colorado
United States	01L_Northshore University Health System	Evanston	Illinois
United States	Northwell Health Physician Partners Orthopaedic Institute at Great Neck	Great Neck	New York
United States	Hoag Orthopedics	Irvine	California
United States	24_Unity Surgical Center, LLC	Lafayette	Indiana
United States	Southern Oregon Orthpaedics	Medford	Oregon
United States	Orthopaedic Specialist of Northwest Indiana	Munster	Indiana
United States	03L_Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Desert Institute for Spine Care (DISC)	Phoenix	Arizona
United States	Summit Spine	Portland	Oregon
United States	Sutter Health	Sacramento	California
United States	Central Cost Neurological Surgery	San Luis Obispo	California
United States	Cervical Disc Center of Los Angeles	Santa Monica	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	Consulting Orthopaedic Associates	Toledo	Ohio
United States	St. Joseph's Medical Center	Wayne	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Xtant Medical	MCRA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Evaluation	Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events, revision, additional stabilizations	Procedure, 6 week, 12, 24, 36, 48, 60 Months
Primary	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
Primary	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
Primary	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	Change in Oswestry Disability Index (ODI)	Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.	Baseline, 24 and 60 months
Secondary	Change in Visual Analog Scale (VAS) for low back pain	Low back pain reduction evaluated by use of VAS for back pain. In terms of achieving at least a 20 point improvement.	Baseline, 24 and 60 Months
Secondary	Change in Visual Analog Scale (VAS) for leg pain	Leg pain reduction evaluated by use of VAS for leg pain. In terms of achieving at least a 20 point improvement.	Baseline, 24 and 60 Months
Secondary	Neurological Status	Assessment of maintenance of improvement after surgery.	Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Secondary	Radiographic Assessments	Significant migration or complete expulsion of implant; Spinous process fracture; Maintenance of foraminal height; adjacent level disease	6 weeks, 12, 24, 60 Months
Secondary	Modified CCS	CCS will be modified to include no use of a narcotic (opioids or opiates).	24 Month
Secondary	Medication Usage	No use of narcotic (opioids and/or opiates)	24 Month