First results with 100 implanted LP-ESP after one year
Afshar, H. ; Scholz, S. ; Koenig, S. ; Mesbah, A. ; Kamangari,A. - Klinikum Leer, Germany
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The LP-ESP II is a one piece deformable implant made of silicon gel with micro voids and surrounded by polycarbonate polyurethane securely fixed to titanium endplates. This implant achieves 6 degrees of freedom, including shock absorption and elastic return. The authors report the first results with 100 implanted LP-ESP after one year.
Material and methods
The geometry of LP-ESP II as the first bi-composite polymeric implant with 6 degrees of freedom allows limited rotation and translation with elastic return. This should authorize more liberty to the rotation centre and a growing resistance in each direction of solicitation to avoid hyper solicitation on posterior facet joints. We implanted the prosthesis through a anterior (Retroperitoneal or Transperitoneal) device for L3/4, L4/5 and L5/S1 levels. Medical data and Oswestry disability questionnaire also Oswestry Low Back Pain Scale and visual analog pain scale were prospectively analyzed. After achieving of pre-op data were a follow up in 3, 6 and 12 months. The study includes a final follow-up in 24 months.
A total of 100 patients who had undergone a Lumbar Totaldisc replacement in segments L3/4, L4/5 or L5/S1. Also patients with a Bisegmental TDR. There were 58 (58%) male and 42 (42%) female patients with a mean age of 45 years. 52% had a previous surgery with a Microdiscektomy. The indications covered a disc herniation, recurrent herniation, lost of disc height and osteochondrosis. Instability was a contraindication. Evaluated by the VAS score, the pain relief during the follow-up was statistically significant. At the time of the investigation, sciatica had totally disappeared, Low back pain had also recovered completely or markedly diminished. There was no significant difference in the occurrence of the pain between male and female patients but between those with or without a previous surgery. The employment of the patient did not affect the outcome.
Disc height was fully restored after implantation. The disc height of the adjacent upper level did not change during the follow-up. No intraoperative complication occurred. There was no device related complication. Clinical scores were all significantly improved.
The LP-ESP II seems to recreate a function to the lumbar spine similar to the Human disc in terms of movement quality, effect on sagittal balance and absence of modification in the kinematics of the upper adjacent level. In the present investigation, the outcome of patients who had undergone a lumbar total disc replacement was successful both regarding the pain relief and capacity to work. Also evaluated by the VAS score, the postoperative pain relief in these patients was statistically significant.