JOURNAL ARTICLE

Pedicle screw-based dynamic stabilization of the thoracolumbar spine with the Cosmic-system: a prospective observation

Michael Stoffel, Michael Behr, Andreas Reinke, Carsten Stüer, Florian Ringel, Bernhard Meyer
Acta Neurochirurgica 2010, 152 (5): 835-43
20084412

OBJECT: The objective of the study was to generate prospective data to assess the clinical results after dynamic stabilization with the Cosmic system (Ulrich Medical).

PATIENTS AND METHODS: Between April 2006 and December 2007, 103 consecutive patients were treated with Cosmic for painful degenerative segmental instability +/- spinal stenosis. The preoperative workup included radiological (MRI and myelography/CT) and clinical parameters (general/neurological examination, visual analogue scale (VAS), Oswestry disability index (ODI), SF-36, Karnofsky (KPS)). At pre-defined intervals (at discharge, 6 weeks, 3 months, 6 months, 12 months, and yearly) the patients were reevaluated (X-ray/flexion/extension, neurological status, VAS, ODI, SF-36, KPS, and patient satisfaction). Data were collected in a prospective observational design.

RESULTS: Data collection was completed in 100 of 103 operated patients (mean follow-up, 15 +/- 0.6 months). Dynamic stabilization was performed as first-tier surgery in 43 cases and as second-tier therapy in 60 cases. Additional decompression was performed in 83 cases. Dynamic stabilization led to significant reduction of back pain-related disability (ODI pre-op, 51 +/- 1%; post-op, 21 +/- 1%) and improvement of pain (VAS pre-op, 65 +/- 1; post-op, 21 +/- 2), mental/physical health (norm-based SF-36: mental pre-op, 44; post-op, 48; physical pre-op, 41; post-op, 46), and mobility (KPS pre-op, 70 +/- 1; post-op, 82 +/- 31). Early reoperation was necessary in 12 patients (n = 3 symptomatic misplaced screws, n = 8 CSF pseudocele, rebleeding, or impaired wound healing, n = 1 misjudged instability/stenosis in adjacent segment). Reoperations within the follow-up period were necessary in another 10 patients due to secondary screw loosening (n = 2), persistent stenosis/disk protrusion in an instrumented segment (n = 3), symptomatic degeneration of an adjacent segment (n = 6), or osteoporotic fracture of an adjacent vertebra (n = 1), respectively. Patient satisfaction rate was 91%.

CONCLUSIONS: Dynamic stabilization with Cosmic achieved significant improvement of pain, related disability, mental/physical health, and mobility, respectively, and a high rate of satisfied patients. A reoperation rate of 10% during follow-up seems relatively high at first glance. Comparable data, however, are scarce, and a prospective randomized trial (spondylodesis vs. dynamic stabilization) is warranted based on these results.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
20084412
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"