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The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AttraX Putty | Active Comparator | Patient will be treated with AttraX Putty intraoperatively. |
|
| Iliac Crest Bone Graft (ICBG) | Active Comparator | Patients will be treated with ICBG harvested during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AttraX Putty | Biological |
| ||
| Iliac Crest Bone Graft (ICBG) |
| Measure | Description | Time Frame |
|---|---|---|
| The number and percentage of subjects with radiographically apparent fusion 24 months. | The number and percentage of subjects with radiographically apparent fusion 24 months. | 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of complications attributable to the use of AttraX and ICBG autograft. | The rate of complications attributable to the use of AttraX and ICBG autograft. | Post-op to 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiano M Menezes, M.D. | Lifecenter to Mater Dei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Dei Hospital | Barro Preto | Minas Gerais | 30140-093 | Brazil |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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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 morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate. | 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 |