Strains in trussed spine interbody fusion implants are modulated by load and design.

Titanium cages with 3-D printed trussed open-space architectures may provide an opportunity to deliver targeted mechanical behavior in spine interbody fusion devices. The ability to control mechanical strain, at levels known to stimulate an osteogenic response, to the fusion site could lead to development of optimized therapeutic implants that improve clinical outcomes. In this study, cages of varying design (1.00 mm or 0.75 mm diameter struts) were mechanically characterized and compared for multiple compressive load magnitudes in order to determine what impact certain design variables had on localized strain. Each cage was instrumented with small fiducial sphere markers (88 total) at each strut vertex of the truss structure, which comprised of 260 individual struts. Cages were subjected to a 50 N control, 1000 N, or 2000 N compressive load between contoured loading platens in a simulated vertebral fusion condition, during which the cages were imaged using high-resolution micro-CT. The cage was analyzed as a mechanical truss structure, with each strut defined as the connection of two vertex fiducials. The deformation and strain of each strut was determined from 50 N control to 1000 N or 2000 N load by tracking the change in distance between each fiducial marker. As in a truss system, the number of struts in tension (positive strain) and compression (negative strain) were roughly equal, with increased loads resulting in a widened distribution (SD) compared with that at 50 N tare load indicating increased strain magnitudes. Strain distribution increased from 1000 N (+156 ± 415 µÎµ) to 2000 N (+180 ± 605 µÎµ) in 1.00 mm cages, which was similar to 0.75 mm cages (+132 ± 622 µÎµ) at 1000 N load. Strain amplitudes increased 42%, from 346µÎµ at 1000 N to 492µÎµ at 2000 N, for 1.00 mm cages. At 1000 N, strain amplitude in 0.75 mm cages (481µÎµ) was higher by 39% than that in 1.00 mm cages. These amplitudes corresponded to the mechanobiological range of bone homeostasis+formation, with 63 ± 2% (p < .05 vs other groups), 72 ± 3%, and 73 ± 1% of struts within that range for 1.00 mm at 1000 N, 1.00 mm at 2000 N, and 0.75 mm at 1000 N, respectively. The effective compressive modulus for both cage designs was also dependent on strut diameter, with modulus decreasing from 12.1 ± 2.3 GPa (1.25 mm) to 9.2 ± 7.5 GPa (1.00 mm) and 3.8 ± 0.6 GPa (0.75 mm). This study extended past micro-scale mechanical characterization of trussed cages to compare the effects of design on cage mechanical behavior at moderate (1000 N) and strenuous (2000 N) load levels. The findings suggest that future cage designs may be modulated to target desired mechanical strain regimes at physiological loads.

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).

Hamstrings tendon graft preparation for anterior cruciate ligament reconstruction using the WhipKnot™ soft tissue cinch technique.

BACKGROUND: Appropriate graft tension and secure graft incorporation in bone tunnels are essential for successful anterior cruciate ligament (ACL) reconstruction using hamstrings tendon autografts. The WhipKnot™ soft tissue cinch, introduced by Smith and Nephew in 2004, is an alternative option to the commonly used whipstitch technique during preparation of the hamstring autograft in ACL reconstruction. AIMS: To investigate the effectiveness of the WhipKnot™ soft tissue cinch and technique during the preparation of the tendon graft for ACL reconstruction. METHOD: A total of 33 ACL reconstruction operations performed between February 2011 and December 2011 were included in this study. These were performed by a single senior surgeon who used the Whipknot™ technique for the preparation of each graft. Four were used for each operation; two for each end of the harvested hamstrings tendons, including semitendinosus and gracilis tendons respectively. RESULTS: In total, 132 WhipKnots were used during the knee operations. Use of the WhipKnot™ technique resulted in successful graft preparations, tensioning and effective graft placement in the tibial and femoral tunnels in almost all instances. Only one case of WhipKnot™ failure (slippage) was recorded. CONCLUSION: These results indicate that the Whipknot™ technique is a safe, reliable and practical option for the preparation of the hamstrings autografts.

Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article.

OBJECT: Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy. METHODS: The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate. RESULTS: A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group). CONCLUSIONS: Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.