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| ID | Type | Description | Link |
|---|---|---|---|
| 20180146 | Other Identifier | Ethics comitee |
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| Name | Class |
|---|---|
| Ortotech | UNKNOWN |
| CeraPedics, Inc | INDUSTRY |
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The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.
Current treatment of LSS is varied ranging from non-operative conservative treatment to operation.
Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended.
The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this difficult patient population.
The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumented spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.
Se above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allograft group, standard treatment | Active Comparator | Control group, standard treatment. Approx 50 g pr level fused. |
|
| i-FACTOR | Experimental | i-FACTOR putty in the operation site. Fda approved. Approx 5 ml pr level fused. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-FACTOR | Procedure | Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested allograft. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry disability index | questionnaire | At 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dallas pain questionnaire | questionnaire | At 24 months |
| Walking distance | measuring distance | At 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikkel Andersen, MD | Department of spine surgery of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middelfart spine surgery research department | Middelfart | 5500 | Denmark |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| D050762 | Cyclin-Dependent Kinase Inhibitor p15 |
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Allograft | Procedure | Approx 50 g of allograft bone in the fused site |
|
| EQ5D | questionnaire | At 60 months |
| SF-36 | questionnaire | At 60 months |
| Fusion status yes/no | Obtained by CT-scan | At 60 months |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D050756 | Cyclin-Dependent Kinase Inhibitor Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D018797 | Cell Cycle Proteins |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |