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Closure of the annulus fibrosus of the intervertebral disc using a novel suture application device – in vivo porcine and ex-vivo biomechanical evaluation
Ist Teil von
The spine journal, 2016-07, Vol.16 (7), p.889-895
Ort / Verlag
United States: Elsevier Inc
Erscheinungsjahr
2016
Quelle
MEDLINE
Beschreibungen/Notizen
Structured Abstract Background Context Defects in the annulus fibrosus (AF) remain a challenge in the surgical treatment of lumbar disc herniations with persistent defects allowing potential re-herniation of nucleus pulposus (NP) tissue. A cervical porcine model was chosen to simulate human lumbar IVD. Purpose To determine the technical feasibility of closure of the annulus fibrosus (AF) of the intervertebral disc (IVD) using a novel minimally invasive Kerrison-shaped suture application device Study Design Ex vivo biomechanical and in vivo porcine device evaluation Methods Ex vivo : 15 porcine spinal units were explanted and subject to mock discectomy. The annular defect was closed using 2-0 non-absorbable (UHMWPE) suture and Dines knot. The knot was backed up with 2, 3 or 4 throws. The spinal unit was subject to 4000 cycles of flexion/extension with 1500N of axial load, and assessed for knot slippage. In vivo : 3 pigs (53-57 kg) were anaesthetised and underwent a ventral surgical approach to the cervical spine. The AF of two discs was incised and simulated partial NP discectomy performed. The defect was closed at one level using the AnchorKnotTM device to apply the suture with a Dines knot and 4 throws. The pigs were observed for 4 weeks before euthanasia allowing 7T MRI and histological evaluation. This study was funded by an industry-match grant of $75000 CAN from the Ontario Centres of Excellence. Results A Dines knot with 4 throws experienced no slippage after 4000 cycles. This configuration was tested in vivo. Clinically, the neurological examination in treated pigs was normal following surgery. Histological and MRI assessment confirmed sustained defect closure at four weeks. There was no reaction to the suture material and no nucleus pulposus extrusion at any of the sutured levels. Conclusions This study demonstrates that it is technically feasible to perform AF defect closure in a porcine model. This novel device achieved AF defect closure that was maintained through four weeks in vivo.