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Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion.
J Neurosurg Spine. 2012 Dec; 17(6):504-11.JN

Abstract

OBJECT

The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD).

METHODS

Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion. Radiographic follow-up data 5 years after treatment were available for 123 TDR patients and 43 fusion patients. To characterize adjacent-level degeneration (ALD), radiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. At 5 years, changes in ALD (ΔALDs) compared with the preoperative assessment were reported.

RESULTS

Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). Among the patients without adjacent-level disease preoperatively, new findings of ALD at 5 years posttreatment were apparent in only 6.7% of TDR patients and 23.8% of fusion patients (p = 0.008). Adjacent-level surgery leading to secondary surgery was reported for 1.9% of TDR patients and 4.0% of fusion patients (p = 0.6819). The TDR patients had a mean preoperative index-level range of motion ([ROM] of 7.3°) that decreased slightly (to 6.0°) at 5 years after treatment (p = 0.0198). Neither treatment group had significant changes in either ROM or translation at the superior adjacent level at 5 years posttreatment compared with baseline.

CONCLUSIONS

At 5 years after the index surgery, ProDisc-L maintained ROM and was associated with a significantly lower rate of ΔALDs than in the patients treated with circumferential fusion. In fact, the fusion patients were greater than 3 times more likely to experience ΔALDs than were the TDR patients. Clinical trial registration no.: NCT00295009.

Authors+Show Affiliations

Texas Back Institute, Plano, Texas 75093, USA. jackzigleer@juno.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23082849

Citation

Zigler, Jack E., et al. "Five-year Adjacent-level Degenerative Changes in Patients With Single-level Disease Treated Using Lumbar Total Disc Replacement With ProDisc-L Versus Circumferential Fusion." Journal of Neurosurgery. Spine, vol. 17, no. 6, 2012, pp. 504-11.
Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. 2012;17(6):504-11.
Zigler, J. E., Glenn, J., & Delamarter, R. B. (2012). Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. Journal of Neurosurgery. Spine, 17(6), 504-11. https://doi.org/10.3171/2012.9.SPINE11717
Zigler JE, Glenn J, Delamarter RB. Five-year Adjacent-level Degenerative Changes in Patients With Single-level Disease Treated Using Lumbar Total Disc Replacement With ProDisc-L Versus Circumferential Fusion. J Neurosurg Spine. 2012;17(6):504-11. PubMed PMID: 23082849.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. AU - Zigler,Jack E, AU - Glenn,Jamieson, AU - Delamarter,Rick B, Y1 - 2012/10/19/ PY - 2012/10/23/entrez PY - 2012/10/23/pubmed PY - 2013/2/16/medline SP - 504 EP - 11 JF - Journal of neurosurgery. Spine JO - J Neurosurg Spine VL - 17 IS - 6 N2 - OBJECT: The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD). METHODS: Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion. Radiographic follow-up data 5 years after treatment were available for 123 TDR patients and 43 fusion patients. To characterize adjacent-level degeneration (ALD), radiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. At 5 years, changes in ALD (ΔALDs) compared with the preoperative assessment were reported. RESULTS: Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). Among the patients without adjacent-level disease preoperatively, new findings of ALD at 5 years posttreatment were apparent in only 6.7% of TDR patients and 23.8% of fusion patients (p = 0.008). Adjacent-level surgery leading to secondary surgery was reported for 1.9% of TDR patients and 4.0% of fusion patients (p = 0.6819). The TDR patients had a mean preoperative index-level range of motion ([ROM] of 7.3°) that decreased slightly (to 6.0°) at 5 years after treatment (p = 0.0198). Neither treatment group had significant changes in either ROM or translation at the superior adjacent level at 5 years posttreatment compared with baseline. CONCLUSIONS: At 5 years after the index surgery, ProDisc-L maintained ROM and was associated with a significantly lower rate of ΔALDs than in the patients treated with circumferential fusion. In fact, the fusion patients were greater than 3 times more likely to experience ΔALDs than were the TDR patients. Clinical trial registration no.: NCT00295009. SN - 1547-5646 UR - https://www.unboundmedicine.com/medline/citation/23082849/Five_year_adjacent_level_degenerative_changes_in_patients_with_single_level_disease_treated_using_lumbar_total_disc_replacement_with_ProDisc_L_versus_circumferential_fusion_ L2 - https://thejns.org/doi/10.3171/2012.9.SPINE11717 DB - PRIME DP - Unbound Medicine ER -