Solid radiographic fusion with a nonconstrained device 5 years after cervical arthroplasty

2014 ◽  
Vol 21 (6) ◽  
pp. 951-955 ◽  
Author(s):  
Robert F. Heary ◽  
Ira M. Goldstein ◽  
Katarzyna M. Getto ◽  
Nitin Agarwal

Cervical disc arthroplasty (CDA) has been gaining popularity as a surgical alternative to anterior cervical discectomy and fusion. Spontaneous fusion following a CDA is uncommon. A few anecdotal reports of heterotrophic ossification around the implant sites have been noted for the BRYAN, ProDisc-C, Mobi-C, PRESTIGE, and PCM devices. All CDA fusions reported to date have been in devices that are semiconstrained. The authors reported the case of a 56-year-old man who presented with left C-7 radiculopathy and neck pain for 10 weeks after an assault injury. There was evidence of disc herniation at the C6–7 level. He was otherwise healthy with functional scores on the visual analog scale (VAS, 4.2); neck disability index (NDI, 16); and the 36-item short form health survey (SF-36; physical component summary [PSC] score 43 and mental component summary [MCS] score 47). The patient underwent total disc replacement in which the DISCOVER Artificial Cervical Disc (DePuy Spine, Inc.) was used. The patient was seen at regular follow-up visits up to 60 months. At his 60-month follow-up visit, he had complete radiographic fusion at the C6–7 level with bridging trabecular bone and no motion at the index site on dynamic imaging. He was pain free, with a VAS score of 0, NDI score of 0, and SF-36 PCS and MCS scores of 61 and 55, respectively. Conclusions This is the first case report that identifies the phenomenon of fusion around a nonconstrained cervical prosthesis. Despite this unwanted radiographic outcome, the patient's clinical outcome was excellent.

2004 ◽  
Vol 17 (3) ◽  
pp. 62-68 ◽  
Author(s):  
Neil Duggal ◽  
Gwynedd E. Pickett ◽  
Demytra K. Mitsis ◽  
Jana L. Keller

Object Spinal arthroplasty may become the next gold standard for the treatment of degenerative cervical spine disease. This new modality must be studied rigorously to ensure in vivo efficacy and safety. The authors review the preliminary clinical experience and radiographic outcomes following insertion of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN). Methods This prospective cohort study included 26 patients undergoing single- or two-level implantation of the Bryan artificial cervical disc for treatment of cervical degenerative disc disease resulting in radiculopathy and/or myelopathy. Radiographic and clinical assessments were made preoperatively 1.5, 3 months, and at 6, 12, and up to 24 months postoperatively. The Neck Disability Index (NDI) and Short Form–36 (SF-36) questionnaires were used to assess pain and functional outcomes. Segmental sagittal rotation from C2–3 to C6–7 was measured using quantitative motion analysis software. A total of 30 Bryan discs were placed in 26 patients. A single-level procedure was performed in 22 patients and a two-level procedure in the other four. Follow-up duration ranged from 1.5 to 27 months, with a mean duration of 12.3 months. A statistically significant improvement in the mean NDI scores was seen between pre- and late postoperative follow-up evaluations. A trend toward improvement in the SF-36 physical component was also found. Motion was preserved in the treated spinal segments (mean range of motion 7.8°) for up to 24 months postsurgery. The relative contribution of each segment to overall spinal sagittal rotation differed depending on whether the disc was placed at C5–6 or C6–7. Overall cervical motion (C2–7) was moderately increased on late follow-up evaluations. Conclusions The Bryan artificial cervical disc provided in vivo functional spinal motion at the treated level. Overall cervical spinal motion was not significantly altered. Sagittal rotation did not change significantly at any level after surgery.


2016 ◽  
Vol 25 (5) ◽  
pp. 556-565 ◽  
Author(s):  
Hans-Jörg Meisel ◽  
Lubomír Jurák ◽  
Jussi Antinheimo ◽  
Ricardo Arregui ◽  
Bernhard Bruchmann ◽  
...  

OBJECTIVE Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis. METHODS A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis. RESULTS Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from −2.4° preoperatively to −6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment. CONCLUSIONS The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR. Clinical trial registration no.: NCT02492724 (clinicaltrials.gov)


2010 ◽  
Vol 13 (6) ◽  
pp. 715-721 ◽  
Author(s):  
Domagoj Coric ◽  
Joseph Cassis ◽  
John D. Carew ◽  
Margaret O. Boltes

Object Cervical total disc replacement (TDR) was developed to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. To establish an evidence-based rationale for cervical TDR to serve as a viable alternative to ACDF, cervical arthroplasty must establish equivalent or superior clinical outcomes while maintaining motion. The authors report on 98 patients from a single investigational site involved in 3 separate prospective, randomized, controlled investigational device exemption multicenter trials comparing cervical arthroplasty to ACDF with a 2–6-year follow-up. Methods Patients with 1- and 2-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively under 3 separate investigational device exemption pivotal trials to undergo ACDF with plate or artificial disc placement. The 3 arthroplasty systems evaluated were the Bryan cervical disc, Kineflex/C disc, and Discover cervical disc. The patients were evaluated with pre- and postoperative serial neurological examinations, radiographs, and clinical outcome indices at 1, 3, 6, 12, 24, 36, 48, and 60 months. Results Ninety-eight patients were treated at the authors' single investigational site. Fifty-seven of these patients underwent cervical arthroplasty and 41 underwent ACDF. A minimum 24-month follow-up was available for 90 patients (92%; 53 in the combined arthroplasty group and 37 in the combined ACDF group) with a follow-up duration ranging from 24 to 67 months (mean 38 months). Clinical success, defined as a composite measure consisting of 5 separate components, was significantly higher in the combined arthroplasty group (85%) compared with the combined ACDF group (70%; p = 0.035). The Neck Disability Index and visual analog scale patient self-report measures were evaluated at 3–24-months follow-up, and all groups showed excellent clinical outcomes. All groups (Bryan, Kineflex/C, Discover, and ACDF) showed statistically significant improvement from the preoperative period to a minimum 2-year follow-up (p < 0.0001). Overall, angular motion was improved by 0.91° in the combined arthroplasty group and reduced by 7.8° in the combined ACDF group (p < 0.0001). In the ACDF group there was a fusion rate of 97% (36 of 37 cases). In the arthroplasty group there was a 5.6% incidence of bridging heterotopic ossification (3 cases). There were a total of 4 reoperations (7.5%) in the combined arthroplasty group with 1 (1.9%) at the adjacent level. There were 3 reoperations (8.1%) in the ACDF group, all at the adjacent level. Conclusions The prospective, intermediate-term (average follow-up > 3 years) results of cervical TDR at the authors' site are encouraging. Patients treated with the artificial discs showed significantly better clinical results, maintained motion at the treated level, and trended toward less adjacent-level disease.


2013 ◽  
Vol 18 (1) ◽  
pp. 85-95 ◽  
Author(s):  
Domagoj Coric ◽  
Kenneth Pettine ◽  
Andrew Sumich ◽  
Margaret O. Boltes

Object The purpose of the study was to evaluate the safety and initial efficacy of NuQu allogeneic juvenile chondrocytes delivered percutaneously for the treatment of lumbar spondylosis with mechanical low-back pain (LBP). NuQu is a cell-based biological therapy for disc repair. The authors report the results at 12 months of the NuQu Phase I investigational new drug (IND) single-arm, prospective feasibility study for the treatment of LBP for single-level degenerative disc disease (Pfirrman Grades III–IV) at L3–S1. Methods Fifteen patients (6 women and 9 men) were enrolled at 2 sites. Institutional review board approval was obtained, and all patients signed a study-specific informed consent. All patients have completed a minimum of 1 year of follow-up. Patients were evaluated pretreatment and at 1, 3, 6, and 12 months posttreatment. Evaluations included routine neurological examinations, serum liver and renal function studies, MRI, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the 36-Item Short Form Health Survey (SF-36). Results Fifteen patients were treated with a single percutaneous delivery of NuQu juvenile chondrocytes. The mean patient age was 40 years (19–47 years). Each treatment consisted of 1–2 ml (mean injection 1.3 ml) of juvenile chondrocytes (approximately 107 chondrocyte cells/ml) with fibrin carrier. The mean peak pressure during treatment was 87.6 psi. The treatment time ranged from 5 to 33 seconds. The mean ODI (baseline 53.3, 12-month 20.3; p < 0.0001), NRS (baseline 5.7, 12-month 3.1; p = 0.0025), and SF-36 physical component summary (baseline 35.3, 12-month 46.9; p = 0.0002) scores all improved significantly from baseline. At the 6-month follow-up, 13 patients underwent MRI (one patient underwent CT imaging and another refused imaging). Ten (77%) of these 13 patients exhibited improvements on MRI. Three of these patients showed improvement in disc contour or height. High-intensity zones (HIZs), consistent with posterior anular tears, were present at baseline in 9 patients. Of these, the HIZ was either absent or improved in 8 patients (89%) by 6 months. The HIZ was improved in the ninth patient at 3 months, with no further MRI follow-up. Of the 10 patients who exhibited radiological improvement at 6 months, findings continued to improve or were sustained in 8 patients at the 12-month follow-up. No patient experienced neurological deterioration. There were no disc infections, and there were no serious or unexpected adverse events. Three patients (20%) underwent total disc replacement by the 12-month follow-up due to persistent, but not worse than baseline, LBP. Conclusions This is a 12-month report of the clinical and radiographic results from a US IND study of cell-based therapy (juvenile chondrocytes) in the treatment of lumbar spondylosis with mechanical LBP. The results of this prospective cohort are promising and warrant further investigation with a prospective, randomized, double-blinded, placebo-controlled study design. Clinical trial registration no.: BB-IND 13985.


Medicina ◽  
2021 ◽  
Vol 57 (6) ◽  
pp. 530
Author(s):  
Ryszard Tomaszewski ◽  
Artur Gap ◽  
Magdalena Lucyga ◽  
Erich Rutz ◽  
Johannes M. Mayr

Background and objectives: Occipital condyle fractures (OCF) occur rarely in children. The choice of treatment is based on the Anderson–Montesano and Tuli classification systems. We evaluated the outcome of unstable OCF in children and adolescents after halo-vest therapy. Materials and Methods: We treated 6 pediatric patients for OCF, including 3 patients (2 girls, 1 boy) with unstable OCF. Among the 3 patients with unstable OCF, 2 patients presented with an Anderson–Montesano type III and Tuli type IIB injury, while 1 patient had an Anderson–Montesano type I fracture (Tuli type IIB) accompanied by a C1 fracture. On admission, the children underwent computed tomography (CT) of the head and cervical spine as well as magnetic resonance imaging (MRI) of the cervical spine. We treated the children diagnosed with unstable OCF with halo-vest immobilization. Before removing the halo vest at the end of therapy, we applied the CT and MRI to confirm OCF consolidation. At follow-up, we rated functionality of the craniocervical junction (CCJ) based on the Neck Disability Index (NDI) and Questionnaire Short Form 36 Health Survey (SF-36). Results: All children achieved OCF consolidation after halo-vest therapy for a median of 13.0 weeks (range: 12.5–14.0 weeks). CT and MRI at the end of halo-vest therapy showed no signs of C0/C1 subluxation and confirmed the correct consolidation of OCF. The only complication associated with halo-vest therapy was a superficial infection caused by a halo-vest pin. At follow-up, all children exhibited favorable functionality of the CCJ as documented by the NDI score (median: 3 points; range: 3–11 points) and SF-36 score (median: 91 points; range: 64–96 points). Conclusions: In our small case series, halo-vest therapy resulted in good mid-term outcome in terms of OCF consolidation and CCJ functionality. In pediatric patients with suspected cervical spine injuries, we recommend CT and MRI of the CCJ to establish the diagnosis of OCF and confirm stable fracture consolidation before removing the halo vest.


2021 ◽  
Vol 10 (6) ◽  
pp. 1185
Author(s):  
Siegmund Lang ◽  
Carsten Neumann ◽  
Lasse Fiedler ◽  
Volker Alt ◽  
Markus Loibl ◽  
...  

Background: It remains questionable if the treatment of cervical fractures with dynamic plates in trauma surgery provides adequate stability for unstable fractures with disco-ligamentous injuries. The primary goal of this study was to assess the radiological and mid-term patient-reported outcome of traumatic subaxial cervical fractures treated with different plate systems. Patients and Methods: Patients, treated with anterior cervical discectomy and fusion (ACDF) between 2001 and 2015, using either a dynamic plate (DP: Mambo™, Ulrich, Germany) or a rigid locking plate (RP: CSLP™, Depuy Synthes, USA), were identified. For radiological evaluation, the sagittal alignment, the sagittal anterior translation and the bony consolidation were evaluated. After at least two years, the patient-reported outcome measures (PROM) were evaluated using the German Short-Form 36 (SF-36), Neck Disability Index (NDI) and the EuroQol in 5 Dimensions (EQ-5D) scores. Results: 33 patients met the inclusion criteria (DP: 13; RP:20). Twenty-six patients suffered from AO Type B or C fractures. Both the sagittal alignment and the sagittal translation could be sufficiently improved in both groups (p ≥ 0.05). No significant loss of reduction could be observed at the follow-up in both groups (p ≥ 0.05). Bony consolidation could be observed in 30 patients (DP: 12/13 (92%); RP: 18/20 (90%); (p ≥ 0.05)). In 20 patients, PROMs could be evaluated (follow-up: 71.2 ± 25.5 months). The whole cohort showed satisfactory PROM results (EQ-5D: 72.0 ± 4.9; SF-36 PCS: 41.9 ± 16.2, MCS: 45.4 ± 14.9; NDI: 11.0 ± 9.1). without significant differences between the DP and RP group (p ≥ 0.05) Conclusion: The dynamic plate concept provides enough stability without a difference in fusion rates in comparison to rigid locking plates in a population that mostly suffered fragile fractures.


2007 ◽  
Vol 7 (5) ◽  
pp. 496-502 ◽  
Author(s):  
Iman Feiz-Erfan ◽  
Mary Harrigan ◽  
Volker K. H. Sonntag ◽  
Timothy R. Harrington

Object In a double-blind randomized study, platelet concentrate was used to treat 50 patients who underwent anterior cervical fusion with allograft bone and internal fixation, predominantly for degenerative disc disease or soft herniated cervical disc. The goal in this study was to compare the outcomes in patients treated with and without the platelet gel. Methods Patients were assessed radiographically at 6, 12, and 52 weeks and at 2 years if needed. Clinically, patients were evaluated with the visual analog scale, Neck Disability Index, Short Form–36, and a modified Prolo Scale. Results Follow-up included 90% of the patients at 1 year and 84% at 2 years. The overall fusion rate was 84%. Conclusions Whereas patients with degenerative discs treated with platelet gel demonstrated early fusion at the 12-week follow-up interval, no consistent early fusion was obtained with the use of the platelet gel preparation in patients with a soft disc herniation.


Author(s):  
Se Jun Oh ◽  
Sang Heon Lee

BACKGROUND: Aquatic exercise can improve strength, flexibility, and aerobic function while safely providing partial weight-bearing support through viscosity and buoyancy. OBJECTIVE: The aim of the present study was to compare the effects of water-based exercise with land-based exercise before and after a 10-week exercise intervention and again at one-year follow-up. METHODS: Eighty participants aged 65 years and older were randomly assigned to either a water- or a land-based 10-week exercise program. Assessment included the Senior Fitness Test (SFT), the Modified Falls-Efficacy Scale, and the 36-Item Short-Form Health Survey (SF-36). Hip and knee strength was also measured. All assessments were completed at three time points: pre- (T1), post- (T2), and at 1-year follow-up (T3). RESULTS: Significant differences were observed between the two groups on three parameters: the SFT timed up-and-go test; lower hip muscle strength in extension, adduction, and external rotation; and quality of life (QoL) measured by the SF-36 (p< 0.05). No significant differences were observed in the SFT chair stand test, dominant arm curl test, two-minute step test, chair sit-and-reach test, back scratch test, and Modified Falls-Efficacy Scale. CONCLUSION: Aquatic exercise provided greater improvement of physical health and QoL among older people than land-based exercise.


2021 ◽  
pp. 107110072110199
Author(s):  
Hakan Bahar ◽  
Kadir Ilker Yildiz

Background: In this study, our aim was to determine the effect of cosmetic improvement on patient satisfaction and functional scores in hallux valgus (HV) surgery. Methods: Preoperative foot photographs of 105 patients who had undergone chevron osteotomy for HV between 2016 and 2018 were taken. The patients were divided into 2 groups. Twenty-four months after surgery, the preoperative foot photographs were shown to patients in group 1 (n = 52) but not to patients in group 2 (n = 53). The groups were then compared using the visual analog scale (VAS), the American Orthopaedic Foot & Ankle Society Hallux Metatarsophalangeal-Interphalangeal (AOFAS Hallux MTP-IP), and the 36-Item Short Form Health Survey (SF-36) scores. Both groups were evaluated radiologically with preoperative and postoperative hallux valgus angles and intermetatarsal angles. Results: There was no difference between the 2 groups in terms of radiologic parameters either pre- or postoperatively, or AOFAS Hallux MTP-IP scores postoperatively. However, for group 1, the VAS was lower (0.4±0.8 vs 1.8±1.6, P = .003) and both the SF-36 physical functioning (88.3±18.1 vs 79.1±23.2, P = .017) and SF-36 mental health scores were higher (78.8±19 vs 69.2±16.3, P = .022). Conclusion: Visualizing improvement in the cosmetic appearance of the foot appears associated with patients’ perception of subjective pain and functional improvement. We recommend that preoperative foot photographs be taken and recorded. Level of Evidence: Level III, case-control study.


2007 ◽  
Vol 35 (10) ◽  
pp. 1659-1667 ◽  
Author(s):  
Wolf Petersen ◽  
Robert Welp ◽  
Dieter Rosenbaum

Background Previous studies have shown that eccentric training has a positive effect on chronic Achilles tendinopathy. A new strategy for the treatment of chronic Achilles tendinopathy is the AirHeel brace. Hypothesis AirHeel brace treatment improves the clinical outcome of patients with chronic Achilles tendinopathy. The combination of the AirHeel brace and an eccentric training program has a synergistic effect. Study Design Randomized controlled clinical trial; Level of evidence, 1. Methods One hundred patients were randomly assigned to 1 of 3 treatment groups: (1) eccentric training, (2) AirHeel brace, and (3) combination of eccentric training and AirHeel brace. Patients were evaluated at 6, 12, and 54 weeks after the beginning of the treatment protocol with ultrasonography, visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) ankle score, and Short Form-36 (SF-36). Results The VAS score for pain, AOFAS score, and SF-36 improved significantly in all 3 groups at all 3 follow-up examinations. At the 3 time points (6 weeks, 12 weeks, and 54 weeks) of follow-up, there was no significant difference between all 3 treatment groups. In all 3 groups, there was no significant difference in tendon thickness after treatment. Conclusions The AirHeel brace is as effective as eccentric training in the treatment of chronic Achilles tendinopathy. There is no synergistic effect when both treatment strategies are combined. Clinical Relevance The AirHeel brace is an alternative treatment option for chronic Achilles tendinopathy.


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