No Statistical Differences Found Between Patients with 1- or 2-Level ProDisc ReplacementLumbar arthroplasties, or disc replacements in the back, have shown promising results for patients with back injuries that did not respond to other treatments. One manufacturer began producing a second type of prosthesis, the ProDisc II after having success with the ProDisc I.
The authors of this study looked back at the results of patients who had undergone disc replacement with either product and compared their outcomes in order to determine if one was better than the other. To be included in the study, the patients could not have had a spinal fusion (joining of the discs).
The average age of the 38 males and 21 females in the study group was 39 years. There were 27 patients in the ProDisc I group and 32 in the ProDisc II group. Patients were evaluated before surgery, at six weeks, three months, six months, one year, 18 months, and two years after surgery. The patients were assessed using the Oswestry Disability Index (ODI), the Short Form Health survey (SF-36), and the Visual Analog Scale (VAS) for pain. Of the patients available at two-year follow up, there were 25 one-level patients (out of 27) and 29 two-level patients (out of 32).
The arthroplasties in the one-level group were performed at L5-S1 in 17 patients and at L4-L5 in the remaining patients. In the two-level group, 29 patients received arthroplasty at L4-L5 and L5-S1, and three at L3-L4 and L4-L5.
Prior to surgery, most of the patients had complaints of back pain for less than one year. Seventy percent also complained of leg pain. The surgical procedures in the one-level group resulted in one complication during surgery (a tear in the ileac vein, which was repaired immediately). Two patients continued to have pain and inflammation at the nerve roots (radiculopathy) and required pain medication through an epidural, fluid administered directly into the spine. One more patient continued to have radiculopathy and had further surgery three months after the arthroplasty. In the two-level group, there were no complications during surgery. Four patients experienced six problems total after the surgery. Two patients had blood clots (thrombosis and a left foot drop, which fully resolved. The third patient had further surgery a year later and the fourth patient had a vertebral fracture at L5; the implant was removed and the spine was fused at that section.
When the patients in the one-level group were evaluated for pain, their VAS score was an average of 71.7 before surgery, dropping to 45.2 at six weeks after surgery, and dropping more to 38.2 at two years. In the two-level group, VAS average score dropped from 75.5 before surgery to 43.4 at six weeks and 47.9 at two years. The ODI, which measures disability, in the one-level group dropped from 63.3 before surgery to 39 at two years after surgery. In the two-level group, the drop went from 63.2 before surgery to 45.7 at two years after surgery. Finally, the SF-36 evaluation, examining the physical ability by rising numbers, in the one-level group rose from 30.9 before surgery to 38.1 at three months after surgery, dropping to 36.4 at one year, and rising again to 39.1 at two years after surgery. In the two-level group, the score rose from 30.9 before surgery to 38.1 at three months after surgery, stayed at 38.6 at one year, and then rose to 39.0 at two years after surgery.
The authors write that they were not able to find any major differences between the two ProDisc replacements.
Matthew Hannibal, MD, et al. ProDisk-L Total Disc Replacement. In Spine. October 2007. Vol. 32. No. 21. Pp. 2322-2326.
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