Degenerative Conditions of the Lumbar Spine
Conditions
Keywords
Degenerative disc disease, Lumbar spine
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.
Interventions
BIOLOGICALAttraX Putty
OTHERIliac Crest Bone Graft (ICBG)
Sponsors
NuVasive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed