AttraX® Putty in spinal fusio

Completed

• Conditions: Degenerative conditions of the lumbar and cervical spine; Musculoskeletal Diseases; Spondylopathies

• Registration Number: ISRCTN38726728
• Lead Sponsor: uVasive, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-15
• Study Completion: 2013-12-01
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Persistent arm pain unresponsive to conservative treatment for at least 6 weeks or persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
2. Indicated for anterior cervical discectomy and fusion (ACDF), anterior lumbar interbody fusion (ALIF or XLIF), or posterior lumbar interbody fusion (PLIF or TLIF) at one or two contiguous motion segments (C3 to T1 in the cervical spine or L1 to S1 in the lumbar spine)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated informed consent form

Exclusion Criteria

1. Mental or physical condition that would limit the ability to comply with study requirements
2. Previous failed fusion at any spinal level
3. Prior fusion procedure at operative level(s) (i.e. no revision of prior level)
4. Prior instrumented fusion at level(s) adjacent to operative level(s)
5. Systemic or local infection; active or latent
6. Diseases that significantly inhibit bone healing (e.g., osteoporosis, metabolic bone disease)
7. Treatment with pharmaceuticals interfering with calcium metabolism
8. Undergoing chemotherapy or radiation treatment
9. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
10. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
11. Significant general illness [e.g., human immunodeficiency virus (HIV), active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease]
12. Immunocompromised or is being treated with immunosuppressive agents
13. Pregnant, or plans to become pregnant during the study
14. A prisoner
15. Participating in another clinical study that would confound study data

Study & Design

• Study Type: Observational
• Study Design: Not specified