Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine

NCT02068729 | Terminated Results DMC

• 1 other identifier: CA-002
• Study Type: observational
• Target: 131
• Locations: 0 countries
• Sites: N/A

Brief Summary

An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

Conditions

Degenerative Disc Disease; Grade 1 Spondylolisthesis

Keywords

degenerative disc disease; DDD; Grade 1 spondylolisthesis; spondylolisthesis; L2-S1

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) Change From Baseline

  Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.

  24 months

• Number of Patients With Adverse Events AEs)

  The evaluation of all adverse events including device related, procedure related and additional serious adverse events.

  Operative to 24 month

Secondary Outcomes (13)

• Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)

  time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

• Change in Oswestry Disability Index From Baseline (Pre-Operative)

  time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

• Change in Health-Related Quality of Life From Baseline (Pre-op)

  time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months

• Radiographic Assessments

  12 mo to 24 mo

• Patient Satisfaction

  12 month and 24 month

Eligibility Criteria

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

Study Population

Patients eligible for study enrollment will have a primary diagnoses limited to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Qualified patients will have confirmed failure of conservative therapy as well as plain film imaging studies. Subjects must be ≥ 18 years old at the time of enrollment.

You may qualify if:

• Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1
• Inadequate response to conservative medical care over a period of at least 6 months
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent
• Skeletally mature and ≥ 18 years of age at the time of enrollment

You may not qualify if:

• Previous anterior/posterior/lateral spine surgery at the index level
• Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine
• Active systemic infection or infection at the operative site
• Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
• Metabolic bone disease such as osteoporosis that contradicts spinal surgery
• History of an osteoporotic fracture
• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• Known allergy to titanium, cobalt chrome or PEEK
• Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
• Current medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
• Pregnant, or intend to become pregnant, during the course of the study
• Severe obesity (Body Mass Index \> 40)
• Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life
• Involved in current or pending spinal litigation where permanent disability benefits are being sought

Sponsors & Collaborators

• K2M, Inc.: lead

Related Publications (4)

• Malham GM, Ellis NJ, Parker RM, Seex KA. Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.

  PMID: 23213282 BACKGROUND

• Caputo AM, Michael KW, Chapman TM Jr, Massey GM, Howes CR, Isaacs RE, Brown CR. Clinical outcomes of extreme lateral interbody fusion in the treatment of adult degenerative scoliosis. ScientificWorldJournal. 2012;2012:680643. doi: 10.1100/2012/680643. Epub 2012 Sep 24.

  PMID: 23049476 BACKGROUND

• Youssef JA, McAfee PC, Patty CA, Raley E, DeBauche S, Shucosky E, Chotikul L. Minimally invasive surgery: lateral approach interbody fusion: results and review. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S302-11. doi: 10.1097/BRS.0b013e3182023438.

  PMID: 21160394 BACKGROUND

• Berjano P, Balsano M, Buric J, Petruzzi M, Lamartina C. Direct lateral access lumbar and thoracolumbar fusion: preliminary results. Eur Spine J. 2012 May;21 Suppl 1(Suppl 1):S37-42. doi: 10.1007/s00586-012-2217-z. Epub 2012 Mar 9.

  PMID: 22402840 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Marissa Conrad, Senior Director of Clinical and Medical Affairs
• Organization: Stryker Spine

marissa.conrad@stryker.com

201-749-8162

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 21, 2014
• Study Start: June 1, 2014
• Primary Completion: September 11, 2019
• Study Completion: February 28, 2020
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-04