142. PROSPECTIVE CLINICAL AND RADIOGRAPHIC RESULTS OF THE CHARITE TOTAL DISC REPLACEMENT: AVERAGE FIVE-YEAR FOLLOW-UP

Abstract

Purpose: To report the clinical and radiographic prospective results of a consecutive series of patient with a minimum two year follow-up with the Charite Total Disc Arthroplasty (TDA).

Method: Between 2001 and 2005, sixty patients underwent a Charite TDA (Depuy Spine, Raynham, MA) at either L4-5 or L5-S1. The primary indication for surgery was discogenic low back pain confirmed by provocative discography. Clinical assessment was carried out preoperatively and postoperatively at 3, 6, 12 months, and once a year thereafter using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) for back and leg pain, and SF-36. Radiographic analysis included: angle of sagittal rotation, translation of the rostral vertebra onto the caudal vertebra, anterior vertical motion (AVM), middle vertical motion (MVM), posterior vertical motion (PVM), pre- and post-operative lumbar lordosis, disc height and subsidence of the TDA. The radiographic measurements were performed using the GE Medical Systems Centricity PACS Software Version 1.0.

Results: There were 36 female and 24 male patients with a mean age of 39 (range 21–59). The mean duration of low back pain was 70 months. Twenty-five percent claimed work compensation status. The mean postoperative hospital stay was 4.8 days. A statistical significant improvement was demonstrated between the mean pre-operative ODI (50) and all post-operative intervals (p< 0.0001) which had declined to 27.7 by one year. Similarly, pre-operative VAS back pain (8.0), leg pain (6.1), SF-36 physical component summary score (33.5) and mental component summary score (41.8) remained improved (p< 0.0001) by three months (4.1, 3.1, 51.7, 62.0 respectively). One patient with an L5-S1 TDA has since undergone a posterolateral instrumented fusion. The mean pre- and post-operative lumbar lordosis was 34.58 and 53.48 respectively. The mean saggital rotation was 6.5 degrees at 5 year follow-up, while the mean translation was 0.83 mm. The mean AVM, MVM and PVM were 0.59 mm, −3.96 mm and 3.69 mm respectively at 5 year follow-up.

Conclusion: This study demonstrates satisfactory clinical results in carefully selected patients. The radiographic assessment confirmed preservation of movement at the replaced disc during flexion and extension of the lumbar spine.