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| Name | Class |
|---|---|
| Apatech, Inc. | INDUSTRY |
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This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inductigraft | Experimental | open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inductigraft | Device | Synthetic bone graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rate | Assessed by x-ray and CT scan | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rate | fusion rate at 6 and 24 months by x-ray/CT scan | 6 and 24 months after surgery |
| Clinical Outcome Measure - pain | Assessed by VAS scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ciaran Bolger | Beaumont Hospital, Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Bonn | Bonn | Germany | ||||
| University of Cologne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30834972 | Derived | Bolger C, Jones D, Czop S. Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study. Eur Spine J. 2019 Jul;28(7):1733-1742. doi: 10.1007/s00586-019-05926-1. Epub 2019 Mar 5. |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6, 12 and 24 months |
| Clinical Outcome measure - Quality of Life | Oswestry Disability Index | 6,12,and 24 months |
| Clinical Outcome measure - Quality of Life | SF-36 v2 short form, health questionnaire | 6,12,and 24 months |
| Adverse events | Assessment of Adverse events | 0-24 months after surgery |
| Cologne |
| Germany |
| Ludwig-Maximilians-Universität München | München | Germany |
| Buda Health Center | Budapest | Hungary |
| University of Debrecen | Debrecen | Hungary |
| Beaumont Hospital | Dublin | Dublin | 9 | Ireland |
| Fundacio Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Clinical de Barcelona & Clinical Corachan | Barcelona | Spain |
| HGU Gregorio Marañón | Madrid | Spain |
| University Hospital of Wales | Cardiff | United Kingdom |
| Queens Medical Centre | Nottingham | United Kingdom |
| Royal Preston Hospital | Preston | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | United Kingdom |
| Shire Southhampton Hospital | Southhampton | United Kingdom |
| Musgrove Park Hospital | Tauton | United Kingdom |