Kelly Baker

A Biomechanical Comparison of Open and Thoracoscopic Anterior Spinal Release in a Goat Model

Study Design. A biomechanical assessment of anterior release and discectomy in the thoracic spine was performed on an animal model using thoracoscopic and open thoracotomy techniques. Objectives. To compare the relative efficacy of these two techniques of release in achieving increased spinal mobility. Background Data. The clinical use of video‐assisted thoracoscopy in the correction of spinal deformity is increasing. The effectiveness of thoracoscopic anterior spinal release with discectomy has not been evaluated biomechanically. Methods. Anterior release with discectomy was performed on six midthoracic motion segments in five mature goats. The thoracoscopic technique was used for three levels on one side, and an open thoracotomy was used for the alternating three levels of the contralateral side. The duration of surgery for disc excision and the amount of blood loss for each technique were recorded. The intact cranial and caudal motion segments served as controls. The motion segments were individually subjected to nondestructive biomechanical testing. Torsional, sagittal, and coronal bending torques were applied, and the resulting angular displacement was measured. Results. The duration of surgery to remove a disc thoracoscopically decreased as experience was gained by the surgeon. The amount of intraoperative blood loss was comparable using the two methods. There was significantly increased flexibility in the released segments with both techniques, compared with the flexibility in the intact levels for all three loading directions. There was no difference in the motion obtained after release between the two techniques. Conclusion. Open and thoracoscopic anterior release and discectomy have been demonstrated, through biomechanical in vitro testing, to increase the flexibility of the spine to a similar extent.

Clinical Outcomes With Selectively Constrained Secure-c Cervical Disc Arthroplasty: Two-year Results From a Prospective, Randomized, Controlled, Multicenter Investigational Device Exemption Study

Study Design. Prospective, multicenter, randomized, and controlled Investigational Device Exemption clinical trial. Objective. To compare the clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, PA) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). Summary of Background Data. Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion. Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation. Methods. A total of 380 patients from 18 investigational sites were prospectively enrolled in the study. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Clinical outcomes include overall success, visual analogue scale pain (right arm, left arm, and neck), neck disability index, neurological status, Short Form 36 (SF-36) Health Status Survey questionnaires, range of motion, and adverse events. Bayesian statistical methods were used to analyze the outcomes. Results. Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at 24 months, with a posterior probability of 100% using the protocol-specified criteria and 98.1% using Food and Drug Administration-defined criteria. At 24 months postoperatively, SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index, visual analogue scale, and 36-Item Short Form Health Survey. At 24 months, the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group (2.5%) than the ACDF group (9.7%). At 24 months, 84.6% of as-treated SECURE-C patients were range-of-motion successes. Satisfaction was high among SECURE-C patients. Conclusion. The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care, an anterior cervical discectomy and fusion. SECURE-C is statistically superior in terms of overall success, index-level subsequent surgical procedures, and patient satisfaction, making it an attractive surgical option for patients with symptomatic cervical disc disease. Level of Evidence: 1

Three-dimensional computer analysis of complex acetabular insufficiency.

Fourteen patients with acetabular dysplasia were studied by using three-dimensional computed tomography (CT) reconstructions before pelvic osteotomies. Computer manipulation of the data allowed a preoperative visual assessment of acetabular shape, assessment of potential congruency between the femoral head and acetabulum by using a mathematical best-fit sphere, and measurement of surface contact distances that depict joint coverage and relate to concentration of weight-bearing forces. Preoperative evaluation of the three-dimensional images for these 14 patients allowed improved understanding of their abnormal anatomy and better surgical planning.

Three-dimensional analysis of clubfoot deformity by computed tomography.

The bony pathoanatomy of clubfoot has been assessed by a three dimensional reconstruction of transverse CT images obtained from 27 feet in children aged 3–10 years. Principal axes of the bones were determined to quantitate interosseous deformity, while visual inspection of the reconstructed images demonstated intraosseous deformity. “Medial spin” and midfoot adduction were analyzed on the AP view of the foot (“top” view), while hindfoot pronosupination was analyzed on the AP view of the ankle (posterior view). This technique allows visualization of deformities which normally cannot be analyzed on plain radiographs, and also shows that a variety of interosseous relationships make up the clinical entity known as clubfoot. Abnormal talar pronation (“intorsion”) was an unexpected finding of this three dimensional analysis.

Effect of spinal construct stiffness on short segment fusion mass incorporation

Study Design Three segment (L3-L5) pedicle screw constructs were implanted in caprine spines, and the resulting ankylosis evaluated mechanically and compared 12 weeks after surgery. Objectives To determine if a construct of maximal stiffness could impair the biologic process of spinal arthrodesis by “stress-shielding.” Summary of Background Data Fusion mass stiffness is believed to be enhanced by increasing construct stiffness, although previous studies have used semirigid, nonconstrained constructs, which lose stiffness through cyclical loading. Device-related osteoporosis, reported to occur with stiff, constrained implants, may be more related to the presence of fusion induced by the implants rather than the implants themselves. Methods In 15 goats, L3-L5 segments were instrumented with pedicle screws, and four different diameters of rods (3.2 cm, 4.8 cm, 6.4 mm, and no rods) were implanted as longitudinal connections to vary the stiffness of the constructs. After 12 weeks, animals were killed and the segments were tested to determine their stiffness. Results In lateral bending, spines “fused” with rods (any size) were significantly stiffer (P = 0.03) than nonrodded spines. There was a trend toward stiffer segments with larger rods (4.8 cm or 6.4 mm) compared with 3.2 mm or no rods. There was a highly significant (P < 0.0001) increase in stiffness of all operated (rodded or nonrodded) segments compared with unoperated controls. Conclusions The enhancement of segmental stiffness by stiffer constructs was confirmed, suggesting a beneficial effect on spinal arthodesis by increasing stiffness, Stress shielding could not be shown.

Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial

ABSTRACT Background: This research was initiated to compare the long-term clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, Pennsylvania) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). To preserve segmental motion, cervical total disc replacement (CTDR) was developed as an alternative to ACDF. Current CTDR designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulation with various means of fixation. Methods: Eighteen investigational sites participated in this prospective clinical trial; 380 patients were enrolled and treated in the investigational device exemption study. The first 5 patients treated at each site were nonrandomized and received the investigational SECURE-C device. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, 24 months, and annually thereafter through 84 months postoperative. Results: Overall results for the randomized cohorts demonstrated statistical superiority of the investigational SECURE-C group over the control ACDF group at 84 months postoperative. SECURE-C showed clinically significant improvement in pain and function in terms of neck disability index and visual analog scale scores, and superiority in patient satisfaction was also achieved for patients treated with SECURE-C. Conclusion: Clinical study results indicated that the selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as ACDF. Long-term results from the Post Approval Study demonstrated that SECURE-C is statistically superior to ACDF in terms of overall success and patient satisfaction. Lower rates of subsequent index-level surgeries and device-related adverse events were observed in the SECURE-C group than in the ACDF group. The long-term, level 1 clinical evidence presented here is consistent with other reports supporting the safety and efficacy of cervical arthroplasty, and furthers advocacy for motion preservation as a viable alternative to fusion.