AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

NCT ID: NCT02704689

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2017-01-19

Brief Summary

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.

Detailed 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.

Conditions

Degenerative Disc Disease; Spondylolisthesis, Grade 1; Retrolisthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AccuLIF

Group Type: EXPERIMENTAL

AccuLIF expandable TLIF cage

Intervention Type: DEVICE

AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.

Interventions

AccuLIF expandable TLIF cage

AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Choma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Health Care

Locations

University of Missouri Health Care

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

510(k) 132505 & K143616

Identifier Type: OTHER

Identifier Source: secondary_id

2015-L-001

Identifier Type: -

Identifier Source: org_study_id