Metanalysis of Heterotopic Ossification (HO) Following Cervical Artificial Disc Replacement (CADR) (original) (raw)
Related papers
European Spine Journal, 2010
Cervical total disc replacement (CTDR) aims to decrease the incidence of adjacent segment disease through motion preservation in the operated disc space. Ongoing data collection and increasing number of studies describing heterotopic ossification (HO) resulting in decreased mobility of implants, forced us to carefully evaluate our long-term clinical and morphological results of patients with CTDR. We present the first 54 consecutive patients treated with 65 ProdiscC TM prostheses during a 12-month period (2/2004-3/2005). All patients signed an informed consent and were included in prospective long-term study approved by hospital ethical committee. The 1-and 2-year follow-up analysis were available for all patients included and 4-year results for 50 patients (60 implants). Clinical (neck disability index-NDI, visual analog scale-VAS) and radiological follow-up was conducted at 1-, 2-and 4-years after the procedure. The Mehren/Suchomel modification of McAfee scale was used to classify the appearance of HO. Mean preoperative NDI was 34.5%, VAS for neck pain intensity 4.6 and VAS for arm pain intensity 5.0. At 1-, 2-and 4-year follow-up, the mean NDI was 30.7, 27.2, and 30.4, mean VAS for neck pain intensity 2.5, 2.1 and 2.9 and mean VAS for arm pain intensity pain 2.2, 1.9 and 2.3, respectively. Significant HO (grade III) was present in 45% of implants and segmental ankylosis (grade IV) in another 18% 4 years after intervention. This finding had no clinical consequences and 92% of patients would undergo the same surgery again. Our clinical results (NDI, VAS) are comparable with fusion techniques. Although, advanced non-fusion technology is used, a significant frequency of HO formation and spontaneous fusion in cervical disc replacement surgery must be anticipated during long-term follow-up.
Clinical and Radiological Outcome of a new Total Cervical Disc Replacement Design
SPINE
Study design: Non-randomized prospective and single center clinical trial of the ProDisc Vivo prosthesis. Objective: Investigate the clinical and radiological results of a refined cTDR-the ProDisc Vivowith two years of follow up (FU). The incidence of implant-related complications was recorded as a secondary outcome variable. Summary of Background Data: Previous generations of the ProDisc artificial cervical disc replacement generate high primary stability due to keel-based designs with opening of the anterior cortex during the implantation and subsequent high rates of heterotopic ossifications. Methods: Clinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires. The radiological outcome included the range of motion (ROM) and the occurrence of heterotopic ossifications. The incidence of implant-related complications with new implant design was recorded as a secondary outcome variable. Results: A total of 55 patients received a single level treatment with the ProDisc Vivo cTDR between C3/4 and C6/7, with a follow up rate of 78%. The clinical outcome scores improved in all parameters significantly (p=0.0001) (NDI: 68.3 17.4; VAS arm: 6.3 1.4; VAS neck: 4.9 1.6). The ROM of the index-segment didn't show a significant change (p=0.26) (7.9° 9.2°). Heterotopic ossifications at the index segment was found as grade 0 in 58%, grade 1 in 22%, grade 2 in 10%, grade 3 (with functional impairment of the prosthesis) in 7% and grade 4 in 3% of the cases. We observed three implant-related complications (5.5%), with two implant dislocations anteriorly and one low-grade infect.
Neurosurgery, 2005
ABSTRACTOBJECTIVE:Heterotopic ossification (HO) is a well-known complication in joint replacements, but its occurrence and clinical effect on cervical artificial discs has not yet been studied. The purpose of this study was to investigate the incidence of HO in cervical disc replacement, to identify any associated risk factors for HO, and to examine the relationship of HO with clinical outcomes.METHODS:The patient data for this observational study were obtained from the original Bryan Disc Study by the European Consortium. Occurrence of HO was defined by the McAfee classification on the cervical lateral x-rays at 12 months after surgery. Secondary outcome measurements included Odom's criteria and the Medical Outcomes Study Short-Form 36-Item Health Survey.RESULTS:Sixteen (17.8%) of the 90 studied patients experienced HO, and 6 (6.7%) of these patients experienced Grade 3 and 4 HO. Ten…
Bone Formation in Cervical Total Disk Replacement (CTDR) up to the 6-Year Follow-up
Neurosurgery Quarterly, 2013
Background: Bone formation or so-called heterotopic ossification (HO) has been recognized as a complication of cervical total disk replacement (CTDR), potentially decreasing the range of motion (ROM) or even fusing the operated level. The purposes were to evaluate HO occurrence after CTDR with the PCM device and to determine the corresponding clinical significance. Methods: A prospective functional study and a retrospective radiographic review were performed. Two hundred seventy-two levels with CTDR using PCM device were enrolled. The followup average was 4.5 years (± 1.37; range, 1 to 6). Radiographic images and clinical outcomes were collected. Results: Of the 272 levels studied, 21 (7.7%) revealed some degree of HO. Of these 21 levels, 10 (47.6%) levels were rated to be grade I, 7 (33.3%) were rated as grade II, 3 (14.28%) as grade III, and 1 (4.76%) as grade IV. Whereas 16.9% of the singlelevel cases developed HO, only 4.4% of the multilevel cases had some bone formation. Surprisingly, the HO patient group did not demonstrate a worsening of the clinical outcome. In 90.5% of patients with HO, preoperative radiographs showed an incipient osteophyte. The mean ROM in flexion-extension images was 11.2 degrees postoperatively, decreasing to 8.3 degrees at 12 months postoperatively and to 6.0 degrees at 72 months. Conclusions: The incidence of HO has a low rate in our series and does not seem to adversely affect clinical outcomes up to this point. Nevertheless, it is an important event that influenced the mean ROM after 72 months and may be further studied for assessment of any late consequences.
European Spine Journal, 2021
Purpose Heterotopic ossification (HO) may cause unintended fusion in artificial disk replacement (ADR), failing to preserve motion. The reported incidence of HO varies hugely. This study aimed to determine prevalence of HO, progression, predisposing factors to occurrence and to progression, and potential effect on clinical outcomes. Methods Eighty-three patients treated with ADRs for cervical radiculopathy at one or two segments were extracted from a previously published RCT. Of the 83 patients, 59 had remaining ADR (79 implants) and sufficiently high-quality X-rays at 5 years of follow-up to allow analysis. HO was graded on plain films according to Mehren/Suchomel. Prevalence, progression, predisposing factors and effect on clinical outcome (Neck Disability Index—NDI) were analyzed. Results At 2 years, HO was seen in 46/55 ADR implants (84%), severe enough to affect mobility in 27/55 (49%). At 5 years, HO was seen in 92% of 79 implants, severe in 71%. Male sex was a predisposing fa...
Heterotopic Ossification in Cervical Disc Arthroplasty
Contemporary Spine Surgery, 2017
Lippincott Continuing Medical Education Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Lippincott Continuing Medical Education Institute designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. To earn CME credit, you must read the CME article and complete the quiz and evaluation assessment survey on the enclosed form, answering at least 70% of the quiz questions correctly. This activity expires on April 30, 2018. LEARNING OBJECTIVES: After participating in this CME activity, the spine surgeon should be better able to: 1. Delineate the occurrence of heterotopic ossification (HO) and assess its severity after cervical disc arthroplasty. 2. Discuss and understand the clinical implications of HO. 3. Identify the risk factors for HO and manage the ways to avoid such complications after cervical disc arthroplasty.
Global spine journal, 2017
Systematic review and meta-analysis. The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions. A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed. These were all randomized controlled trials comparing anterior cervical discectomy and fusion (ACDF) to TDR. Important outcome variables were dysphagia, wound infection, neurologic injuries, heterotopic ossification, death, and secondary surgeries. A random effects model was selected a priori. Data on adverse events was abstracted and analyzed by calculating relative risk of ACDF to TDR by meta-analysis techniques. The study included 3027 patients with 1377 randomized to ACDF and 1652 to TDR. No statistical differences were present between the 2 groups in dysphagia/dysphonia,...
Journal of Neurosurgery: Spine, 2011
Object Heterotopic ossification (HO) after cervical total disc replacement (TDR) has been reported to impede artificial disc motion. In all previously reported cases of HO, assessment was based on plain radiographs. The authors hypothesized that CT scan is a more sensitive and accurate detector. The aims of this study were to assess the actual incidence of HO and its effect on outcome in a cohort of patients undergoing cervical TDR with the Bryan disc and to compare HO detection by means of plain radiographs and CT. Methods The authors retrospectively assessed data from medical records, radiological studies, and clinical evaluations of patients who underwent 1- or 2-level cervical TDR with the Bryan disc and were followed up for more than 12 months. The presence and grading of HO according to the McAfee classification were assessed by CT scan, and these findings were compared with findings on plain radiographs. Thirty-six patients (mean age 46.61 ± 7.24 years; range 29–60 years; 21 ...
Asian Spine Journal
Our goal was to compare the 2-year clinical and radiological results of artificial disc replacement (ADR) and cage screw (CS) implants in patients with cervical degenerative disc disease (DDD). Overview of Literature: Anterior cervical discectomy and fusion with CS implants are an acceptable alternative to traditional cageplate construct due to perceived decreased complications of dysphagia. However, patients may experience adjacent segment disease because of increased motion and intradiscal pressure. ADR is an alternative to restore the physiological kinematics of the operated disc. Few studies directly compare ADR and CS construct for their efficacy. Methods: Patients who received single-level ADR or CS between January 2008 and December 2018 were included. Data collected was preoperatively, intraoperatively, and postoperatively (6, 12, 24 months). Demographic information, surgical information, complications, follow-up surgery, and outcome ratings (Japanese Orthopaedic Association [JOA], Neck Disability Index [NDI], Visual Analog Scale [VAS] neck and arm, 36-item Short Form Health Survey [SF-36], EuroQoL-5 Dimension [EQ-5D]) were gathered. The radiological assessment included motion segment height, adjacent disc height, lordosis, cervical lordosis, T1 slope, the sagittal vertical axis C2-7, and adjacent level ossification development (ALOD). Results: Fifty-eight patients were included (ADR: 37 and CS: 21). At 6 months, both groups' JOA, VAS, NDI, SF-36, and EQ-5D scores significantly improved, and the positive trends persisted at 2 years. Noted no significant difference in the enhancement of clinical scores except for the VAS arm (ADR: 5.95 vs. CS: 3.43, p=0.001). Radiological parameters were comparable except for the progression of ALOD of the subjacent disc (ADR: 29.7% vs. CS: 66.9%, p=0.02). No significant difference in adverse events or severe complications seen. Conclusions: ADR and CS obtain good clinical results for symptomatic single-level cervical DDD. ADR demonstrated a significant advantage over CS in the improvement of VAS arm and reduced progression of ALOD of the adjacent lower disc. No statistically significant difference of dysphonia or dysphagia between the two groups were seen, attributed to their comparable zero profile.
Clinical and radiographic outcomes of cervical disc replacement with a new prosthesis
The Spine Journal, 2014
BACKGROUND CONTEXT: Anterior cervical discectomy and interbody fusion was a classical treatment for cervical degenerative disc disease (CDDD). However, the rigid fusion also leads to a reduction in normal cervical spine motion and to increased biomechanical stress at adjacent levels, which in turn accelerates degenerative changes of the discs at these levels. Cervical disc replacement (CDR) is a new technology with the aim of addressing the limitations of fusion procession and preserving motion at the treated level. Discover prosthesis (DePuy Spine, Raynham, MA, USA) is a new type artificial disc and there are few reports about it. PURPOSE: The purpose of this study was to analyze the primary clinical and radiographic outcomes of CDR with Discover prosthesis to treat mono-or bi-segment CDDD in a Chinese population. STUDY DESIGN: The study design was prospective and single-center clinical trial of the Discover prosthesis in the treatment of patients with mono-or bi-segment CDDD. PATIENTS SAMPLE: Seventy-nine patients with 102 Discover prosthesis arthroplasty performed (56 mono-segment and 23 bi-segment) were evaluated. OUTCOME MEASURES: Clinical outcomes based on Japanese Orthopaedic Association (JOA), visual analog scale (VAS) pain score, and Odom's scale and radiographic outcomes including the anterior disc heights (ADH), posterior disc heights (PDH), range of motion, and performance of heterotopic ossification (HO) of the operative segment were assessed. METHODS: Clinical and radiographic follow-up was performed. Preoperative and postoperative ADH, PDH, and range of motion were measured from lateral and flexion-extension radiographs. The paired t test was used to assess the difference of clinical and radiographic outcomes before and after operation. The performance of HO was observed by two independent MD. RESULTS: The mean follow-up time for all the patients was 31.6 months, ranging from 24 to 43 months. Mean preoperative JOA score was 9.5, and VAS overall pain score was 7.2. At 2-, 6-, 12-, and 24-month follow-up, the mean JOA score was 14.1, 14.7, 15.3, and 14.9, whereas the mean VAS overall pain score was 1.9, 1.7, 1.8, and 1.4, respectively. Mean JOA and VAS scores showed statistical improvements in the postoperative period. Seven patients had mild dysphagia within the first month after operation. According to Odom's scale, 52 patients had excellent outcomes, 25 patients had good outcomes, and 2 patients had fair outcomes at 2-year follow-up. The Mean preoperative ADH and PDH of the operative segment were 4.9 mm and 3.1 mm. Compared with FDA device/drug status: Investigational (Discover Artificial Cervical Disc). Author disclosures: JM: Nothing to disclose. FY: Nothing to disclose. YS: Nothing to disclose. NH: Nothing to disclose. YK: Nothing to disclose. XW: Nothing to disclose. DC: Nothing to disclose. No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.