AttraX® Putty vs. Autograft in XLIF®

Not Applicable

Completed

• Conditions: Degenerative Conditions of the Lumbar Spine
• Interventions: Biological: AttraX Putty; Other: Iliac Crest Bone Graft (ICBG)

• Registration Number: NCT02250248
• Lead Sponsor: NuVasive

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.

Study Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Study Start: 2014-12
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AttraX Putty	AttraX Putty	Patient will be treated with AttraX Putty intraoperatively.
Iliac Crest Bone Graft (ICBG)	Iliac Crest Bone Graft (ICBG)	Patients will be treated with ICBG harvested during surgery.

Primary Outcome Measures

Name	Time	Method
The number and percentage of subjects with radiographically apparent fusion 24 months.	24-months	The number and percentage of subjects with radiographically apparent fusion 24 months.

Secondary Outcome Measures

Name	Time	Method
The rate of complications attributable to the use of AttraX and ICBG autograft.	Post-op to 24-months	The rate of complications attributable to the use of AttraX and ICBG autograft.
The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.	Pre-op through 24-months	The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.	Surgery through 24-months	The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.

Trial Locations

Locations (1)

Mater Dei Hospital; 🇧🇷 Barro Preto, Minas Gerais, Brazil