Rebecca Barrett-Tuck1, Diana Del Monaco2, Jon E Block3. 1. NEA Baptist Clinic, 4802 E. Johnson Ave., Jonesboro, AR 72401, USA. 2. Wenzel Spine, Inc., 1130 Rutherford Lane, Ste. 200, Austin, TX 78753, USA. 3. 2210 Jackson Street, Ste. 401, San Francisco, CA 94115, USA.
Abstract
BACKGROUND: Surgical interventions such as posterior lumbar interbody fusion (PLIF) with and without posterior instrumentation are often employed in patients with degenerative spinal conditions that fail to respond to conservative medical management. The VariLift® Interbody Fusion System was developed as a stand-alone solution to provide the benefits of an intervertebral fusion device without the requirement of supplemental pedicle screw fixation. METHODS: In this retrospective case series, 25 patients underwent PLIF with a stand-alone VariLift® expandable interbody fusion device without adjunctive pedicle screw fixation. There were 12 men and 13 women, with a mean age of 57.2 years (range, 33-83 years); single level in 18 patients, 2 levels in 7 patients. Back pain severity was reported as none, mild, moderate, severe and worst imaginable at baseline, 6 and 12 months. Preoperatively, 88% (22 of 25) of patients reported severe back pain. RESULTS: All patients experienced symptomatic improvement and, by 12 months postoperatively, 71% (15 of 21) of patients reported only mild residual pain. Overall, pain scores improved significantly from baseline to 12 months (P=0.0002). There were no revision surgeries and fusion was achieved 12 of 13 patients (92%) who returned for a 12-month radiographic follow-up. There were three cases of intractable postsurgical pain which required extended hospitalization or pain management, one wound infection and one case of surgical site dehiscence, both treated and resolved during inpatient hospitalization. CONCLUSIONS: In this single-physician case series, the VariLift® device used in single or two-level PLIF provided effective symptom relief and produced a high fusion rate without the need for supplemental fixation.
BACKGROUND: Surgical interventions such as posterior lumbar interbody fusion (PLIF) with and without posterior instrumentation are often employed in patients with degenerative spinal conditions that fail to respond to conservative medical management. The VariLift® Interbody Fusion System was developed as a stand-alone solution to provide the benefits of an intervertebral fusion device without the requirement of supplemental pedicle screw fixation. METHODS: In this retrospective case series, 25 patients underwent PLIF with a stand-alone VariLift® expandable interbody fusion device without adjunctive pedicle screw fixation. There were 12 men and 13 women, with a mean age of 57.2 years (range, 33-83 years); single level in 18 patients, 2 levels in 7 patients. Back pain severity was reported as none, mild, moderate, severe and worst imaginable at baseline, 6 and 12 months. Preoperatively, 88% (22 of 25) of patients reported severe back pain. RESULTS: All patients experienced symptomatic improvement and, by 12 months postoperatively, 71% (15 of 21) of patients reported only mild residual pain. Overall, pain scores improved significantly from baseline to 12 months (P=0.0002). There were no revision surgeries and fusion was achieved 12 of 13 patients (92%) who returned for a 12-month radiographic follow-up. There were three cases of intractable postsurgical pain which required extended hospitalization or pain management, one wound infection and one case of surgical site dehiscence, both treated and resolved during inpatient hospitalization. CONCLUSIONS: In this single-physician case series, the VariLift® device used in single or two-level PLIF provided effective symptom relief and produced a high fusion rate without the need for supplemental fixation.
Authors: Rakesh D Patel; Gregory P Graziano; Kelly L Vanderhave; Alpesh A Patel; Michael C Gerling Journal: Spine (Phila Pa 1976) Date: 2011-12-15 Impact factor: 3.468
Authors: Andriy Noshchenko; Lilian Hoffecker; Emily M Lindley; Evalina L Burger; Christopher M J Cain; Vikas V Patel Journal: J Spinal Disord Tech Date: 2015-11