AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

NCT02704689 | Terminated Results

• 2 other identifiers: 2015-L-001510(k) 132505 & K143616
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis, Grade 1; Retrolisthesis

Outcome Measures

Primary Outcomes (2)

• Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.

  Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.

  24 months

• Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.

  Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.

  24 months

Secondary Outcomes (12)

• Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.

  Operative Visit

• Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.

  Peri-op

• Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.

  Operative Visit

• Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.

  24 months

• Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings

  24 months

Study Arms (1)

AccuLIF

EXPERIMENTAL

Device: AccuLIF expandable TLIF cage

Interventions

AccuLIF expandable TLIF cage DEVICE

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

AccuLIF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant instability of the spine.
• Requires TLIF at more than 2 levels between L2 and S1.
• Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
• Younger than 18 years of age, or older than 70 years of age.
• BMI of 40 or greater.
• History of metabolic bone disease
• Osteoporosis
• Diabetes mellitus requiring daily insulin management.
• Subject has any of the following:
• Progressive neuromuscular disease; OR
• Autoimmune disease; OR
• Active malignancy within the last 15 years; OR
• Active hepatitis; OR
• AIDS, ARC, or is HIV positive; OR
• Syringomyelia at any spinal level; OR

Sponsors & Collaborators

• Stryker Spine: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

A total of 100 subjects were planned for enrollment. However, this study was terminated early due to lack of enrollment with only 9 enrolled subjects and 6 treated subjects. No subjects reached the 24 month analysis visit.

Results Point of Contact

• Title: Jennifer Warnke
• Organization: Stryker

jennifer.warnke@stryker.com

(201) 749-8000

Study Officials

• Theodore Choma, MD

  University of Missouri Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 10, 2016
• Study Start: June 8, 2016
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: April 24, 2018
• Results First Posted: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)