Abstract
Introduction: Disc Replacement has been described as 21st Century revolution in spinal surgery that preserves mobility and prevents adjacent segment degeneration. Numerous short-term studies are available on clinical outcome but to date there are no published long term clinical, radiological and survival data on disc replacement.
Aim: To analyse clinical, radiological & survival results of Charite III Disc Replacement.
Study Design: Ethical committee approved retrospective study.
Methodology: 160 patients (Av. Age 46yrs; Std.Dev 8.06; 62 Males & 98 Females) underwent disc replacement surgery between Jan1990 and Dec2000. An independent observer reviewed case notes, radiographs and administered a questionnaire that included Oswestry Disability Index, and Pain Score.
Results: Clinical: At an average follow up of 79 (range 31 to 161) months, mean improvement in ODI and pain score were 18.01(p< 0.001) and 1.69(p< 0.001) respectively.
Radiological: average movement at replaced disc, defined as greater than 4 degrees on flexion-extension lateral view was 1.5 degrees for L3L4, 4.01 degrees for L4L5 and 4.8 degrees for L5S1 disc replacement.
Survival: A mean survival time of 147(95% C.I. 140 to 154) months was observed with cumulative survival of 55% with implant removal as an endpoint. A mean survival time of 124(95% C.I. 116 to 133) months with cumulative survival of 35% was observed with all radiological failures as an endpoint.
Complications: were post-operative incisional hernia seen in 17(10.6%), wound infection 9(5.6%) and retrograde ejaculation in 5(3.1%) patients.
Conclusion: Charite III Disc Replacement results in clinically significant (> 15, p< 0.001) improvement in ODI, but does not result in clinical significant (> 2 points) improvement in back pain. Motion is preserved at L4L5 and L5S1 level. It has low survival rate and does not seem to prevent onset of facet arthritis. This study does not support the use of this device for management of back pain.
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