Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up

Background The newly designed cervical disc prosthesis, Pretic-I, had been finished its limited clinical use for over 5 years. At a short-term follow-up of 2 years, we obtained satisfactory clinical results. The long-term clinical efficacy and safety of Pretic-I will now be analyzed. Methods Peri-operative parameters included intra-operative blood loss, operation time, off-bed time. Clinical parameters included visual analogue scale (VAS) for arm and neck, neck disability index (NDI), and Japanese Orthopaedic Association (JOA) score. Radiological parameters included C2–7 Cobb angle, Shell angle, and the range of motion (ROM) of C2–7, functional segment unit (FSU), and adjacent FSU. The CDA-related complications included adjacent segment degeneration (ASDeg), adjacent segment disease (ASDis), heterotopic ossification (HO), prosthesis subsidence, prosthesis displacement, and dysphagia. Results A total 64 patients from two independent centers received a single-level CDA with Discover (n = 32) and Pretic-I (n = 32), and all of patients finished a 5-year follow-up. There’re no significant differences between two groups in peri-operative parameters. The clinical parameters improved greatly in Pretic-I group (p<0.0001), and there’s no statistical difference from Discover group. Furthermore, Pretic-I could slightly improve the cervical curvature (15.08 ± 11.75 to 18.00 ± 10.61, p = 0.3079) and perfectly maintain the Shell angle (3.03 ± 3.68 to 2.23 ± 4.10, p = 0.1988), cervical ROM (52.48 ± 14.31 to 53.30 ± 11.71, p = 0.8062) and FSU ROM (12.20 ± 4.52 to 10.73 ± 4.45, p = 0.2002). The incidence of high-grade HO (Grade III-IV) at the final follow-up was significantly lower in Pretic-I group than in Discover group (12.50% vs. 34.38%, p = 0.0389, Statistical Power = 95.36%). The incidences of other CDA-related complications in Pretic-I group were also well-accepted, comparable to the Discover group, without significant differences. Conclusion CDA with Pretic-I demonstrated a well-accepted and sustained clinical outcome, with a significantly lower incidence of high-grade HO. This newly designed prosthesis is expected to become an alternative choice for cervical disc prosthesis in the future.

Comparison of Pretic-I Versus Discover Disc Arthroplasty As Treatment for Single-level Cervical Disc Degenerative Disease With 5-year Follow-up

Background: The newly designed cervical disc prosthesis, Pretic-I, had been finished its limited clinical use for over 5 years. At a short-term follow-up of 2 years, we obtained satisfactory clinical results. The long-term clinical efficacy and safety of Pretic-I will now be analyzed. Methods: Peri-operative parameters included intra-operative blood loss, operation time, off-bed time. Clinical parameters included visual analogue scale (VAS) for arm and neck, neck disability index (NDI), and Japanese Orthopaedic Association (JOA) score. Radiological parameters included C2-7 Cobb angle, Shell angle, and the range of motion (ROM) of C2-7, functional segment unit (FSU), and adjacent FSU. The CDA-related complications included adjacent segment degeneration (ASDeg), adjacent segment disease (ASDis) , heterotopic ossification (HO), prosthesis subsidence, prosthesis displacement, and dysphagia.Results: A total 64 patients from two independent centers received a single-level CDA with Discover (n=32) and Pretic-I (n=32), and all of patients finished a 5-year follow-up. There’re no significant differences between two groups in peri-operative parameters. The clinical parameters improved greatly in Pretic-I group (p＜0.0001), and there’s no statistical difference from Discover group. Furthermore, Pretic-I could slightly improve the cervical curvature (15.08±11.75 to 18.00±10.61, p=0.3079) and perfectly maintain the Shell angle (3.03±3.68 to 2.23±4.10, p=0.1988), cervical ROM (52.48±14.31 to 53.30±11.71, p=0.8062) and FSU ROM (12.20±4.52 to 10.73±4.45, p=0.2002). The incidence of high-grade HO (Grade III-IV) at the final follow-up was significantly lower in Pretic-I group than in Discover group (12.50% vs. 34.38%, p=0.0389, Statistical Power=95.36%). The incidences of other CDA-related complications in Pretic-I group were also well-accepted, comparable to the Discover group, without significant differences.Conclusion: CDA with Pretic-I demonstrated a well-accepted and sustained clinical outcome, with a significantly lower incidence of high-grade HO. This newly designed prosthesis is expected to become an alternative choice for cervical disc prosthesis in the future.

Prospective Multicenter Trial of Cervical Arthroplasty With the ROTAIO® Cervical Disc Prosthesis

ObjectiveAnterior Cervical Discectomy and Arthroplasty (ACDA) is an established treatment for degenerative cervical disc disease and seems to be an alternative to fusion in minimizing the risk of Adjacent Segment Disease (ASD). The ROTAIO® cervical disc prosthesis is a novel unconstrained implant with a variable center of rotation aiming at physiological motion. The objective of this multicenter prospective trial was to evaluate clinical outcome and complications within 2 years.Material and Methods120 patients (72 females and 48 males with a median age of 43.0 years; range: 23 to 60 years) underwent ACDA (ROTAIO®, SIGNUS Medical, Alzenau, Germany) and were prospectively followed for 24 months. Preoperative complaints were mainly associated with radiculopathy (n=104) or myelopathy (n=16). There were 108 monosegmental and 12 bisegmental procedures including 6 hybrid constructs. Clinical outcome was evaluated at 3, 12 and 24 months by the Visual Analogue Scale (VAS) for head, neck and arm pain, the Neck Disability Index (NDI), the Work Limitation Questionnaire (WL-26), the Patient`s Satisfaction Index (PSI) and a Quality of Life Questionnaire (SF-36). The Nurick Score, the Modified Japanese Orthopaedic Association Score (mJOA) plus a Composite Success Rate have been additionally applied. Finally, complications, the patient`s overall satisfaction and the amount of analgesics were assessed. ResultsHighly significant clinical improvements were observed according to NDI and VAS (p<0.0001 (arm); p<0.001 (neck); p=0.002 (head)) at all postoperative time points. Analgetic medication could be reduced after 3 months in 91.3%, after 12 months in 87.1% and after 24 months in 95.2% of patients. Doctor`s visits for cervical spine problems have been reduced in 93.8% after 24 months.Patient`s overall satisfaction was high after 3, 12 and 24 months with 83.5%, 78.4% and 79.1% of patients, while 4.1%, 6.8% and 7.0% respectively were not satisfied. The composite success rate was 77.5% after 12 months and 76.9% after 24 months. There were no major complications in this series. Slight subsidence of the prosthesis was observed in 2 patients and 3 patients demonstrated fusion after 24 months. 2 patients developed symptomatic foraminal stenosis, so that implant removal and fusion was performed.ConclusionThe ROTAIO® cervical disc prosthesis is a safe and efficient treatment option for symptomatic degenerative disc disease demonstrating excellent clinical results at 2 years. Outcome proves to be stable over time with very low revision rates.

Primary stability of the Activ L® intervertebral disc prosthesis in cadaver bone and comparison of the keel and spike anchoring concept

Background: High primary stability is the key prerequisite for safe osseointegration of cementless intervertebral disc prosthesis. The aim of our study was to determine the primary stability of intervertebral disc prosthesis with two different anchoring concepts – keel and spike anchoring. Methods: 10 ActivL intervertebral disc prosthesis (5 x keel anchoring, 5 x spike anchoring) implanted in human cadaver lumbar spine specimens were tested in a spine movement simulator. Under axial load flexion, extension, left and right bending and axial rotation were applied on the lumbar spine specimens through a defined three-dimensional movement program as per ISO 2631 and ISO/CD 18192-1.3 standards. Micromotion of the implants covering every single movement axis were measured for both anchor types and compared using Student’s T-test for significance after calculating 95% confidence intervals. Results: In the transverse axis, the keel anchoring concept showed lower statistically significant (p<0.05) mean values of micromotion compared to spike anchoring concept. The highest micromotion values for both types were observed in the longitudinal axis. The data achieved the threshold of primary stability (150-200 μm).Conclusions: Both fixation systems fulfil the required criteria of primary stability. Independent of the selected anchorage type an immediate postoperative active mobilization doesn’t compromise the stability of the prostheses.