AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (APROPOS)

Stryker

Status: Terminated

Conditions: Degenerative Disc Disease; Retrolisthesis; Spondylolisthesis, Grade 1

Treatments: Device: AccuLIF expandable TLIF cage

Study type: Interventional

Funder types: Industry

Identifiers

NCT02704689

2015-L-001

510(k) 132505 & K143616 (Other Identifier)

Details and patient eligibility

About

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.

Full description

Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is skeletally mature and between 18 and 70 years of age.
2. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
3. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
4. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
6. Subject agrees to comply with visit schedule and completing study questionnaires.

Exclusion criteria

1. Significant instability of the spine.

2. Requires TLIF at more than 2 levels between L2 and S1.

3. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.

4. Younger than 18 years of age, or older than 70 years of age.

5. BMI of 40 or greater.

6. History of metabolic bone disease

7. Osteoporosis

8. Diabetes mellitus requiring daily insulin management.

9. Subject has any of the following:

   1. Progressive neuromuscular disease; OR
   2. Autoimmune disease; OR
   3. Active malignancy within the last 15 years; OR
   4. Active hepatitis; OR
   5. AIDS, ARC, or is HIV positive; OR
   6. Syringomyelia at any spinal level; OR
   7. Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.

10. Allergy to implant materials (titanium, titanium alloy).

11. Active systemic infection or infection localized to the site of implantation.

12. Primary or metastatic tumors involving the spine.

13. Open wounds or inadequate issue tissue coverage over the operative site.

14. History of significant mental illness or mental incapacity.

15. Pregnancy or intent to become pregnant.

16. Participating in another investigational study for a similar purpose.

17. Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.

18. Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.

19. Workers compensation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

AccuLIF

Experimental group

Treatment:

Device: AccuLIF expandable TLIF cage