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To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.
To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. It is known that the anterior portion of the annulus limits the movement in extension and axial rotation, so removal of this section of the annulus fibrosus will increase the range of movement in extension and axial rotation. As far as the investigators know, this increase in movement ranges has not been measured objectively in alive patients. Also the investigators would like to know if the postoperative prevertebral scar reduces an to what extent these abnormal movement ranges. This could help the investigators to decide when patients should be allowed to regain normal activities and specially, when the patients should be allowed to start working again. The investigators also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved, and thus represents an improvement or not in the care of these patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior annulus removal | Active Comparator | In these patients the anterior portion of the annulus fibrosus will be removed when inserting a complete lumbar disc prosthesis |
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| Anterior annulus replacement | Active Comparator | In these group of patients the anterior portion of the annulus fibrosus will be opened up in to flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is inserted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior lumbar disc annulus removal versus replacement | Procedure | Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales |
| Measure | Description | Time Frame |
|---|---|---|
| Range of spinal segment movement after lumbar disc prosthesis insertion in L4-L5 lumbar disc | The investigators will analyze preoperatively and postoperatively at 3, 6 and 12 months the range of movement of the L4-L5 lumbar disc after insertion of a complete lumbar disc prosthesis | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicente Vanaclocha, MDPhD | Contact | + 34 963 13 18 00 | 438500 | vivava@uv.es; vvanaclo@hotmail.com |
| Teresa Moratal, Secretary | Contact | + 34 963 13 18 00 | 437334 | ceicvalencia_hgv@gva.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Valencia | Recruiting | Valencia | Valencia | 46014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19927100 | Background | Auerbach JD, Jones KJ, Milby AH, Anakwenze OA, Balderston RA. Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2510-7. doi: 10.1097/BRS.0b013e3181af2622. | |
| 29322911 | Background |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
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Two groups. In one the anterior annulus will be removed to insert a lumbar disc prosthesis and in the other this section of the anterior annulus will be opened up in two flaps hinged lateraly and replaced once the complete lumbar disc prosthesis is implanted
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Patients will not be informed if the anterior annulus is removed or replaced
| Huang YJ, Zhao SJ, Zhang Q, Nong LM, Xu NW. Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis. Acta Orthop Belg. 2017 Mar;83(1):180-193. |
| 15950689 | Result | Frelinghuysen P, Huang RC, Girardi FP, Cammisa FP Jr. Lumbar total disc replacement part I: rationale, biomechanics, and implant types. Orthop Clin North Am. 2005 Jul;36(3):293-9. doi: 10.1016/j.ocl.2005.02.014. |