Clinical and radiographic outcomes of dynamic cervical implant replacement for treatment of single-level degenerative cervical disc disease: a 24-month follow-up

Purpose

To determine the role of dynamic cervical implant (DCI) replacement for single-level degenerative cervical disc disease in Chinese patients.

Methods

Thirty patients with single-level degenerative cervical disc disease were prospectively enrolled between April 2010 and August 2010 (12 women, 18 men; mean age 56.5 years). All patients underwent anterior cervical decompression, DCI replacement, clinical and radiological assessments preoperatively and at 1, 6, 12, and 24 months postoperatively, and Japanese Orthopaedic Association (JOA), Visual Analogue Scale (VAS), Neck Disability Index (NDI), and Short Form 36 (SF-36) scores. Lateral neutral radiographs provided the intervertebral space height. Lateral dynamic radiographs were taken to measure the range of motion (ROM) of the cervical spine and functional spinal unit (FSU) of the treated segment. We compared the amount of motion of the adjacent vertebral endplate and the intrinsic motion of the implant and calculated a correlation analysis.

Results

DCI showed good clinical and radiographic outcomes. At the final follow-up, JOA, VAS, NDI, and SF-36 average scores improved significantly. The intervertebral space height increased slightly after operation and was maintained during follow up. The ROM of the cervical spine and FSU decreased at early follow-up, but recovered to the preoperative level within 1–2 years. There was a high index of linear correlation between the motion of the adjacent vertebral endplate and the intrinsic motion of the implant.

Conclusions

DCI provided elastic dynamic stability for the targeted segment, and restored and sustained intervertebral space height and ROM of the cervical spine.     

Clinical outcomes of BRYAN cervical disc arthroplasty: a prospective, randomized, controlled, multicenter trial with 24-month follow-up

STUDY DESIGN/SETTING: Prospective, randomized, 3-center, clinical trial. OBJECTIVE: To prospectively compare the outcomes of cervical arthroplasty with the BRYAN Cervical Disc Prosthesis (Medtronic Sofamor Danek, Inc, Memphis, TN) to anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Surgical treatment of cervical disc pathology commonly involves techniques that employ discectomy and fusion (ACDF). This "gold-standard" technique has demonstrated good clinical and radiographic outcomes. Common adverse effects of this procedure are associated with the adjacent level degeneration and bone-graft harvest. Several investigators have independently reported successful short-term outcomes with the BRYAN Cervical Disc Prosthesis. In addition, a significant body of knowledge has been collected regarding the wear patterns and adjacent level effects of this device in human and animal models. METHODS: As part of an FDA IDE trial, 3 centers collected prospective outcomes data on 115 patients randomized in a 1:1 ratio to ACDF (Control group) or arthroplasty with the BRYAN Cervical Disc Prosthesis (Investigational group). RESULTS: Demographic and surgical data were generally similar in the 2 populations. Outcomes data collected at routine postoperative intervals for 24 months demonstrated that the Investigational group had statistically significant (P<0.05) improvements as assessed by the Neck Disability Index, the Neck Pain Score, and SF-36 Physical component scores. The improvement in the Mental Component Subscore values for the BRYAN and control groups was equivalent at 24 months (P=0.055). Arm pain relief was similar in both groups (P=0.152). During the course of the 2-year follow-up, 4 patients in the Control group required surgical intervention and 3 patients in the Investigational group required ACDF for adjacent level disease. CONCLUSIONS: At 24 months, cervical arthroplasty with the BRYAN Cervical Disc Prosthesis compares favorably with ACDF as defined by standard outcomes scores.     

Clinical and radiological results following cervical arthroplasty

Summary Background. This was a retrospective study of clinical and radiological results of cervical arthroplasty using the Bryan cervical disc prosthesis to evaluate the efficacy of arthroplasty in clinical applications. Methods. A total of 46 patients underwent arthroplasty of a single level using the Bryan disc prosthesis. Clinical outcome was assessed using the visual analogue scale (VAS) and the neck disability index (NDI). All patients were evaluated using preoperative and postoperative static cervical spine radiographs to compare cervical sagittal balance. Dynamic cervical spine radiographs were used to compare movement at the level of the procedure, movement at the adjacent level and movement of the whole cervical spine. Findings. With the exception of four patients with aggravated neck pain, the NDI and VAS scores decreased significantly in late follow-up evaluations. The range of movement of the whole cervical spine, the functional segmental unit, and the adjacent segments were preserved after arthroplasty. The sagittal alignment of the cervical spine showed kyphosis after surgery but restored lordosis at a later time. The postulated cause of kyphotic changes include “over-milling” at the dorsal endplate, inappropriate angle of disc insertion, structural absence of lordosis in the Bryan disc, removal of posterior longitudinal ligament, and pre-existing kyphosis. Conclusions. Arthroplasty using the Bryan disc appears to be safe and provided a favorable preliminary clinical and radiological outcome. Postoperative kyphosis can be prevented by understanding the biomechanical properties of the Bryan disc. Future studies will need to address the association between postoperative kyphosis, clinical outcome and adjacent segment disease.     

单节段人工颈椎间盘置换与前路融合术的对照研究

 目的 观察比较 Prestige LP人工颈椎间盘置换术和经前路颈椎间盘切除植骨融合术(an terior cervical discectomy and fusion, ACDF)治疗单节段颈椎间盘突出症的临床效果。方法 2008年 1月 至 2010年 3月, 87例单节段颈椎间盘突出症患者接受 Prestige LP人工颈椎间盘置换手术(置换组, 44 例)或 ACDF手术(融合组, 43例)。分别在术前, 术后 1周, 术后 3、6、12及 24个月, 对患者进行疼痛视 觉模拟评分(visual analogue scale, VAS)、日本矫形外科协会(Japanese Orthopedics Association, JOA)脊髓 功能评分和生活质量量表(Short Form-36, SF-36)的评估及影像学评估, 同时记录患者并发症及二次手 术情况。结果 78例患者获得平均 12.4个月(6~24个月)随访。两组患者的颈痛、上肢痛 VAS和 JOA评 分, 术后各随访点较术前均有改善(P0.05)。SF-36躯体评分、精神 评分术后各点较术前有明显上升(P0.05), 融合组融合成功率为 92.1%。置换 组中 3例患者在 3个月时假体有<3 mm的前移, 1例患者在术后第 3天发生脑脊液漏;融合组中 2例患 者发生邻椎病并接受二次手术治疗。结论 单节段 Prestige LP人工颈椎间盘置换术治疗颈椎间盘突出 症, 与 ACDF手术一样使患者症状缓解明显, 且对手术节段及邻近节段活动度影响小。     

初次全髋关节置换术后6年以上随访的临床疗效分析

目的评价初次全髋关节置换（THA）术后6年以上的临床疗效及术后的各种并发症。方法自2001年1月至2005年1月,本中心共对北京地区210例225侧髋关节进行初次THA。其中单侧髋关节置换术195例,双髋同时置换术15例。半髋置换10例,全髋关节置换术215例。骨水泥固定假体18例,非骨水泥固定假体207例。围手术期及术后处理基本一致。术后定期随访,最新的随访时间平均为6.5年（5.5~8.5年）。结果围手术期并发症包括：术中股骨干骨折6例;下肢深静脉血栓28例,无肺栓塞病例;术后伤口感染4例;术后4周内脱位3例;术后出现一过性意识障碍3例。术后平均6.5年时176例183髋得到随访,34例42髋失访。远期感染病例1例,脱位2例,股骨干骨折4例。Harris评分由术前平均40.6分（-12~59分）提高到术后平均80.4分（75~94分）。其中152例评分〉80分,19例评分位于70~80分之间,5例评分〈70分。影像学检查3例髋臼假体、4例6髋股骨假体周围出现小范围的透亮线,2例3髋发现位于髋关节周围的异位骨化。其余X线片示髋臼和股骨柄假体位置满意,无松动和感染征象。结论 THA是治疗各种晚期重度髋关节疾病很好的方法,6年以上的临床效果良好,并发症少。     

Mitomycin C in superficial bladder cancer: 24-month follow-up

Twenty-three patients who were given intravesical Mitomycin C for treatment of superficial bladder cancer have been followed up for a further 12 and 24 months after an initial assessment 5 weeks after completing therapy. At 5 weeks 17 (74%) showed complete disappearance of tumour and 4 (17%) showed a partial response. Twelve months later 8 (35%) remained tumour-free and 15 (65%) had recurrences; 5 of these (22% of all patients) had progressed to invasive cancer. The results at 24 months were little different except that one further patient (27% in all) progressed to invasive cancer. Six patients with symptomatic carcinoma in situ became symptom-free after Mitomycin C, but despite remaining free of symptoms three have progressed to invasive cancer. This small series shows that involvement of large areas of bladder urothelium by tumour, carcinoma in situ and previous therapy for tumour are unfavourable prognostic indices.     

Press fit condylar total knee arthroplasty: radiographic evaluation at a 5-year follow-up

The three standard views are necessary for the radiographic evaluation of a total knee arthroplasty, by the measurement of knee alignment, components position and prosthetic interface. We radiographically evaluated 100 Press-Fit Condylar (PFC) total knee replacements in 66 women and 18 men (mean age, 69.5 years), at a mean follow-up of 5 years. The indication for implantation was osteoarthritis in 87% of the cases and rheumatoid arthritis in 11%. Radiographs were done at 3 and 6 months and then every year after implant, and each time were compared to the postoperative controls. The postoperative alignment had in 98% of the knees a valgus angle between 5° and 7°. Radiolucencies were found around the femoral component in 8% of the knees, and in the views of the tibial tray in 33%. The thicknesess of the radiolucent lines was 1 mm and was not progressive in 98% of the prostheses. One case presented aseptic loosening signs. Evaluation of total joint arthroplasty must be clinical, radiological and with annual intervals, in order to discover early failure signs. Concerning the present study, aseptic loosening is not a complication of the total knee arthroplasty evaluated for a medium follow-up of five years. Received: January 2002, Accepted: 15 February 2002 Correspondence to: G. Sandrucci     

A 24-month follow-up after treatment of hallux rigidus with resection arthroplasty in combination with a resorbable polymer-based implant and platelet-rich plasma

Background

Aim of this study was to analyze the clinical outcome after treatment of hallux rigidus with implantation of a resorbable polymer-based implant immersed with autologous platelet-rich plasma (PRP).

Clinical and radiological analysis of Bryan cervical disc arthroplasty: eight-year follow-up results compared with anterior cervical discectomy and fusion

Purpose

Bryan cervical disc arthroplasty has been reported with satisfactory short- and medium-term clinical results. However, the long-term clinical and radiographic outcomes are seldom reported. The purpose of this study was to compare the eight-year follow-up results in patients who underwent Bryan disc arthroplasty with patients received ACDF, and assess the incidence of heterotopic ossification (HO) and its effect on clinical outcome and mobility of the device.

Methods

Thirty-one patients underwent Bryan disc arthroplasty, and 35 patients underwent ACDF were included in the study. The Japanese Orthopedic Association (JOA) scores, neck disability index (NDI), visual analogue scale (VAS) of neck and arm pain, and the radiographs were used to evaluate the outcomes. The heterotopic ossification (HO) was determined by CT scan and was classified into three subgroups to compare the related effect. Adjacent segment degeneration (ASD) was also observed.

Results

At final follow-up, there were no significant differences in JOA scores between two groups, but the improvement in NDI and neck or arm VAS were significantly greater in the Bryan disc cohort. The range of motion at the index level was 7.0° in Bryan group, while 100 % bone fusion were achieved in ACDF group. HO was observed in 18 (51.4 %) levels. There were more restricted movement of the prosthesis and slight higher rate of axial pain in patients with severe-HO (grade III and IV). Fourteen (28.6 %) levels developed ASD in Bryan group, which was significantly lower than that (58.6 %) in ACDF group.

Conclusions

At eight year follow-up, the clinical and radiographic outcomes of Bryan cervical disc arthroplasty compared favorably to those of ACDF. It avoided accelerated adjacent segment degeneration by preserving motion. However, severe HO restricted the ROM of the index levels and maybe associated with post-operative axial pain.

     

陶瓷对陶瓷全髋关节置换术的初步体会

目的回顾分析本组陶瓷对陶瓷全髋关节置换术的临床结果,探讨行全陶人工髋关节置换的手术体会。方法本组在2000年3月~2008年4月间,对行陶瓷对陶瓷全髋关节置换术的患者进行随访,随访时间超过24个月的有202例(269髋),其中男123例(178髋),女79例(91髋),平均年龄46岁,随访时间平均41(24~122)个月。所有这些患者均进行了临床和影像学评估。结果本组患者术前Harris评分平均53.47(3~85)分,术后平均为90.66(59~100)分。术后随访无患者有关节异响的主诉,未见假体松动,未发生假体周围感染,无翻修患者。无可观察到的磨损和骨溶解,无明显异位骨化。本组患者术中出现1例边缘崩裂。四种不同公司的髋臼对患术后Harris评分无显著影响。结论本研究的短期随访结果显示,现代陶瓷对陶瓷全髋关节置换术对于年轻的骨质量较好的患者是一种良好的选择,但需更长期的随访以验证其长期疗效。     

Knee-joint arthroplasty according to Stanmore. A clinical and radiographic follow-up

Of a total of 56 knee arthroplasties according to Stanmore, a clinical and radiographic follow-up was performed on 38, with mean follow-ups of 36 months for rheumatoid arthritis and 34 months for osteoarthritis. Early complications occurred in nine of 56 cases. Clinically satisfactory results were obtained in 71%. Radiolucent zones of 3 mm or more were found to be associated with clinically verified loosening.     

Psychological adjustment following work-related hand injury: 18-month follow-up.

Severe, work-related hand injuries are often accompanied by a significant number of psychological symptoms that are frequently associated with posttraumatic stress disorders. These symptoms occur in the following four domains of psychological functioning: cognitive, affective, physiological, and behavioral. This study examined the incidence of a variety of symptoms occurring with work-injured patients. Interviews were conducted at 1 week, 3 months, 6 months, 12 months, and 18 months after injury. Symptom frequencies were recorded. The results indicate that many of these symptoms were persistent 18 months later and continued to be significantly debilitating. The results support the need for psychological intervention after severe, work-related hand injuries.     

Arthroscopic versus mini-open rotator cuff repair: a prospective,randomized study with 24-month follow-up

This prospective, randomized study was performed to evaluate the results of mini-open and arthroscopic rotator cuff repair in a comparative case series of patients followed for 24 months. A total of 125 patients were randomized to mini-open (Group I) or arthroscopic (Group II) rotator cuff repair at the time of surgical intervention. The University of California Los Angeles (UCLA) score, the American Shoulder and Elbow Surgeons (ASES) index, and muscle strength were measured to evaluate the clinical results, while magnetic resonance arthrography was used at 24-month follow-up to investigate the postoperative rotator cuff integrity. Fifty-three patients in Group I and 55 patients in Group II were available for evaluation at 24-month follow-up. At 24-month follow-up, the UCLA score, the ASES index, and muscle strength were statistically significantly increased in both groups postoperatively, while no significant difference was detected between the 2 groups. Intact rotator cuffs were investigated in 42 patients in Group I and 35 in Group II, and there was a significant difference in postoperative structural integrity between the two groups (P < 0.05). When analysis was limited to the patients with full-thickness tear, the muscle strength of the shoulder was significantly better in Group II, and the retearing rate was significantly higher in Group II. Based on the results obtained from this study, it can be indicated that arthroscopic and mini-open rotator cuff repair displayed substantially equal outcomes, except for higher retearing rate in the arthroscopic repair group. While for patients with full-thickness tear, arthroscopic rotator cuff repair displayed better shoulder strength and significantly higher retearing rate as compared to mini-open rotator cuff repair at 24-month follow-up.     

Effect of age on clinical and radiographic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up

OBJECT: Lumbar arthroplasty is approved in the US for the treatment of degenerative disc disease at 1 level in skeletally mature patients. However, a bias toward older patients (> 45 years of age) who are otherwise indicated for the procedure may exist. In this study, the clinical outcomes of patients from the Charité Investigational Device Exemption (IDE) study were analyzed on the basis of patient age. METHODS: There were 276 patients enrolled in the IDE study of the Charité Artificial Disc who underwent 1-level arthroplasty at either L4-5 or L5-S1, including 71 nonrandomized and 205 randomized individuals. Patient data were analyzed based on age (18-45 years [217 patients, Group 1] compared with 46-60 years [59 patients, Group 2]). Statistical analyses were performed based on 2-year postoperative improvements in Oswestry Disability Index (ODI), 36-item Short Form Health Survey (SF-36), and visual analog scale (VAS) scores (clinical outcome), as well as range of motion (radiographic outcome), and adverse events. RESULTS: There was no significant difference between the groups with respect to level implanted, operative time, blood loss, changes in ODI and VAS scores or any of the 8 component scores of the SF-36, compared with baseline, at all time points throughout the 24-month follow-up period (p > 0.10). Patient satisfaction was equivalent at 24 months, with 87% satisfaction in Group 1 and 85% satisfaction in Group 2 (no statistical difference). In addition, no significant differences were identified with respect to adverse events including approach related, neurological, technique related, or reoperation. CONCLUSIONS: Although patients > 45 years of age may have comorbidities or contraindications for arthroplasty for a number of reasons, particularly osteopenia, this analysis demonstrates that patients who are indicated for 1-level arthroplasty experience similar clinical outcome, satisfaction, or adverse events compared with their younger counterparts.     

Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up

BACKGROUND CONTEXTCervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.PURPOSETo investigate the 10-year follow-up adverse events rates between CDA and ACDF.STUDY DESIGN/SETTINGThe study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.PATIENT SAMPLEn=463 patients.OUTCOME MEASURESAdverse events comparison of CDA and ACDF from self-reported and physiologic measures.METHODSAt each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.RESULTSA total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the “other” category (p=.015).CONCLUSIONSThe cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.