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Cresco’s revolutionary Spring Distraction System™ for early onset scoliosis grows with the spine while correcting the various planes through continuous distraction. This allows for fewer interventions and associated collateral damage, resulting in a better outcome and quality of life.
Cresco is developing Dynamic Implant Solutions™, a line of dynamic implant systems to treat scoliosis.
The Spring Distraction System™ (SDS™) is part of this family of systems. It allows spinal growth and three-dimensional correction in early onset scoliosis. The development was led by a highly experienced spine surgeon team. The SDS™ treatment with the first generation implants has over 5 years of clinical experience and is supported by peer-reviewed literature.
Titanium pedicle screw hold de cobalt chrome rods.
Rods (4.5/5mm) can be shaped to the anatomical requirement and slide through the smooth connectors.
The compressed helical spring, available in various lengths and strengths, fits around the rod and allows for a continuous distraction.
The connector lined with polyethylene (PE) provides a smooth sliding environment for the rod.
Preoperative
The SDS™ is indicated for skeletally immature EOS patients, single or double curved, with a progression > 45°. It allows for an initial correction in the coronal and sagittal plane using contoured rods.
Postoperative
The pretensioned spring mechanism (available in various lengths and strengths) provides a continuous dynamic sliding distraction force. It has the potential to further correct the curve in various planes after implantation while maintaining the uninterrupted growth of the spine without the need for further manual, magnetic or otherwise more invasive lenghtening interventions.
1 Year Follow Up
The result is significant improvement of the scoliotic deformity while allowing a rather normal growth of the spine by 10 mm per year and avoiding damaging of the intervertebral discs.
The SDS™ spring actively stimulates guided growth three-dimensionally, correcting the coronal and saggital plane, while offering the spine a chance to reach its near full natural growth potential.3,5.
Due to posterior placement of the SDS™, there is no need for traumatic intrusion in the thorax. Longer term complications and interference in the growth of the chest cavity will be avoided.
The SDS™ will be used with a standardized pedicle screw system, which warrants an easy integration in current workflow.
Dynamic loading with spring distraction forces in physiological range makes the system less vulnerable to overloading of hardware, stress shielding of vertebral bone, or breaking of screws and rods4,7.
Less frequent hospital visits and surgeries make it easier for the young patient and their family to undergo this treatment with SDS™, as it lowers the impact on the patient and families’ mental health, discomfort and pain.
The second generation of SDS™ has a sliding combination of a wear resistant polyethylene connector and cobalt chrome rod. This significantly decreases the formation of wear particles, which avoids potential triggering of immune cells.
Significant fewer returns for invasive lengthening interventions mean less negative impact on the growing brain and body. Not only does this reduce the potential harmful anesthetic impact, but it also lowers the number of other complications like disturbed wound healing.
By using this dynamic growth system, versus other systems, there is little to no need for periodic manual or surgical distraction. This will lead to fewer returns to the clinic which has a significant positive impact on hospital case load and economics.
The rods, including spring and buttress, can be implanted minimally invasive, thereby minimizing soft tissue disruption and length of skin incision.
The latest version of SDS™ provides various lengths and strenghts of the spring and rod dimensions in order to create the best suitable contoured construct allowing phyiological distraction forces1,4,7.
1
The updated SDS design generated similar curve maintenance and spinal growth compared to the previous system, however with less implant-related complications and unplanned reoperations.
2
Comparison of various systems revealed a growth overestimation caused by effects of curve correction at initial and final surgery.
3
Proof of concept of SDS™. The system maintains growth and has the potential of further correction of the deformity after implantation without further lengthening procedures.
4
Approximate safe distraction forces in the pediatric spine, using a safety factor of 4 would be 200N, 250N and 300 N for respectively age group 5-6, 7-8 and above 9 years old.
5
Using the SDS™ in primary EOS patients , a curve correction of 50% and growth (11.6mm/y) without the need for repetitive lengthening procedures could be obtained.
6
Although the complication rate of MCGR and SDS™ were similar, in the MCGR group the failure to distract and in the SDS™ group implant prominence prevailed.
7
In the FEA TGR treatment resulted in slightly larger curve correction compared to SDS™ at the expense of increased IVD stress-shielding and a higher risk of rod fracture.
1.
Casper S. Tabeling 1, *, Justin V. C. Lemans, Anouk Top, E. Pauline Scholten, Hilde W. Stempels, Tom P. C. Schlösser, Keita Ito, René M. Castelein 1 and Moyo C. Kruyt The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial J. Clin. Med. 2022, 11, 3747
2.
Wijdicks S, Tromp I, Yazici M, Kempen D, Castelein R, Kruyt M. A comparison of growth among growth-friendly systems for scoliosis: a systematic review. The Spine Journal 2019;19:789−799
3.
Wijdicks SPJ, Lemans JVC, Verkerke GJ, Noordmans HJ, Castelein RM, Kruyt MC. The potential of spring distraction to dynamically correct complex spinal deformities in the growing child. Eur Spine J. 2021;30(3):714-723
4.
Lemans JVC, Wijdicks SPJ, Koutsoliakos I, Hekman EEG, Agarwal A, Castelein RM, Kruyt MC. Distraction forces on the spine in early-onset scoliosis: a systematic review and meta-analysis of clinical and biomechanical literature. JBiomech. 2021;124:110571
5.
Lemans JVC, Wijdicks SPJ, Castelein RM, Kruyt MC. Spring Distraction System for Dynamic Growth Guidance of Early Onset Scoliosis: 2 Year Prospective Follow-up of 24 Patients. Spine J. 2021;21(4):671-681
6.
Lemans J, Tabeling C, Castelein R, Kruyt M. Identifying complications and failure modes of innovative growing rod configurations using the (hybrid) magnetically controlled growing rod (MCGR) and the spring distraction system ( SDS). Spine Deformity 2021;9:1679–1689
7.
Lemans J, Kodigudla M, Kelkar A, Jayaswal D, Castelein R Kruyt M, Goel V, Agarwal A. Finite element comparison of the Spring Distraction System and the Traditional Growing Rod for the treatment of Early Onset Scoliosis. Spine 2021
The Cresco team consists of experienced orthopedic surgeons and entrepreneurs with a long track-record in spinal research and the medical industry. We are focused on improving spinal care. Specifically, the dream is to establish new standards for surgical treatment of pediatric spinal deformities based on dynamic implants. We strive to improve the treatment of children and adolescents with severe spinal deformities.
Regulatory
Currently only for use as investigational
device and not available for sale or distribution.
