AttraX® Putty vs. Autograft in XLIF®

NCT ID: NCT02250248

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-05-21

Brief Summary

The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.

Detailed Description

This is a single-center, prospective, randomized study. Subjects will be recruited from patients already under the Investigator's care who are indicated for XLIF with iliac crest bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned. All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.

Conditions

Degenerative Conditions of the Lumbar Spine

Keywords

Degenerative disc disease; Lumbar spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AttraX Putty

Patient will be treated with AttraX Putty intraoperatively.

Group Type: ACTIVE_COMPARATOR

AttraX Putty

Intervention Type: BIOLOGICAL

Iliac Crest Bone Graft (ICBG)

Patients will be treated with ICBG harvested during surgery.

Group Type: ACTIVE_COMPARATOR

Iliac Crest Bone Graft (ICBG)

Intervention Type: OTHER

Interventions

AttraX Putty

Intervention Type: BIOLOGICAL

Iliac Crest Bone Graft (ICBG)

Intervention Type: OTHER

Other Intervention Names

autograft

Eligibility Criteria

Inclusion Criteria

1. 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 a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws

3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies

4. 18-80 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. Spine abnormality requiring treatment at more than one level

3. Previous failed fusion at any spinal level

4. Prior fusion procedure at operative level (i.e., no revision of operative level)

5. Prior adjacent level fusion (note: prior decompression is not an exclusion)

6. Systemic or local infection; active or latent

7. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)

8. Treatment with pharmaceuticals interfering with calcium metabolism

9. Undergoing chemotherapy or radiation treatment

10. 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)

11. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)

12. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)

13. Immunocompromised or is being treated with immunosuppressive agents

14. Pregnant, or plans to become pregnant during the study

15. Subject is a prisoner

16. Participating in another clinical study that would confound study data

17. At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristiano M Menezes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lifecenter to Mater Dei Hospital

Locations

Mater Dei Hospital

Barro Prêto, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

NUVA.AX1401

Identifier Type: -

Identifier Source: org_study_id