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The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis.
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months.
Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSTEOAMP | Active Comparator | OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures |
|
| Infuse | Active Comparator | The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSTEOAMP | Other | OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine. |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Status | Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Status | Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Impairment | Derived from the Oswestry Low Back Pain Questionnaire to quantify low back pain and function. Zero is equated with no disability and 100 is the maximum disability possible. | 24 Months |
| Back Pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Doan | Contact | (901) 341-2976 | amanda.doan@bioventus.com | |
| Adam Waksman, DVM | Contact | adam.waksman@bioventus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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In this study, all subjects will be treated at 2 levels of the anterior lumbar spine. One of the levels will be grafted with OSTEOAMP SELECT and the other with Infuse housed within the same type of interbody cage. The assignment of the bone graft product to each treated motion segment will be randomized in a 1:1 ratio. Every subject will serve as his/her own control.
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| Infuse | Device | The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2. |
|
Visual Analogue Scale (VAS) change in back pain from baseline to 24 month follow up assessed at time frames: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month.
Visual Analogue Scale is rated from 0 - 10 cm (no pain - worst possible pain)
| 24 Months |
| Leg Pain | Visual Analogue Scale (VAS) change in leg pain from baseline to 24 month follow up assessed at time frames: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month. Visual Analogue Scale is rated from 0 - 10 cm (no pain - worst possible pain) | 24 Months |
| Kansas Joint and Spine Specialists | Recruiting | Wichita | Kansas | 67226 | United States |
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| Orthopaedic Institute of Western Kentucky | Recruiting | Paducah | Kentucky | 42001 | United States |
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| Spine Institute of Louisiana | Active, not recruiting | Shreveport | Louisiana | 71101 | United States |
| New England Baptist Hospital | Recruiting | Boston | Massachusetts | 02120 | United States |
|
| Tennessee Orthopaedic Alliance | Recruiting | Nashville | Tennessee | 37209 | United States |
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| Austin Neurosurgeons | Recruiting | Austin | Texas | 78746 | United States |
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| OrthoVirginia | Recruiting | Richmond | Virginia | 23235 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
|
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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