Combination of ionomer cement and bone graft for ossicular reconstruction

The aim of this study was to investigate the efficacy of the reconstruction of large ossicular chain defects with a combination of ionomer cement and an autogenous cortical bone graft. Different individual solutions are described if at least the handle of the malleus is present: restoration of a large defect of the long process of the incus, formation of the incus body and the long process, and replacement of the missing superstructure of the stapes with a short bone graft standing on the footplate. In a unique case, total reconstruction of the malleus handle was carried out. In further cases where the malleus and the incus were absent, the missing superstucture of the stapes was replaced by a bone graft fixed to the remnant of the anterior crus, supplemented with a cortical bone PORP. Between 1993 and 2005, 84 patients underwent middle ear operations with the use of ionomer cement. In 16 ears (9 males, 7 females), a combination of ionomer cement and autogenous cortical bone graft was used for ossicular reconstruction, with a documented follow-up of at least 6 months to 7 years. All operations were performed under general anesthesia. The components of the cement were mixed by hand and transferred to the bare bone surface with a curved needle. Complex structures were built up step by step. In seven cases, the tympanic membrane was simultaneously reconstructed. The postoperative air–bone gap was < 20 dB in 11/16, 68% of the cases. No columella rejection occurred. The reconstructed malleus handle is still intact, though the hearing has deteriorated. The audiological results are encouraging and a further prospective study is under design in order to analyze the efficacy of the combination of ionomer cement and an autogenous cortical bone graft for ossicular reconstruction. The simultaneous reconstruction of the superstructure of the stapes and the long process of the incus or the whole incus makes PORPs or TORPs superfluous, if at least the handle of the malleus is present.     

自体砧骨听骨链成形术的听力重建效果

目的探讨以自体砧骨重建听骨链的开放式IIIa型鼓室成形术的听力改善疗效。方法回顾性收集16例(16耳)因慢性化脓性中耳炎或胆脂瘤中耳炎接受开放式Ⅲa型鼓室成形术患者的临床资料,所有病例均采用自体砧骨进行听骨链重建。术后随访3-6个月,评估患者手术后听力改善情况,分析指标为手术前后言语频率的纯音听阈及气骨导差。结果所有均达到干耳。纯音气导听阈从术前的45.2到干耳。降至术后的30.6的干耳。纯音气导听阈(P<0.05)。术前、术后气骨导差分别为33.1、术后7dB及19.8、术后7dB分别为从术前的析,其中气骨导差小于20dB者占62.5%(10/16)。结论在本组病例中,以自体砧骨行听骨链重建开放式Ⅲa型鼓室成形术,获得了较好的近期听力改善效果,其远期疗效有待于进一步观察。     

Hearing results in pediatric patients with chronic otitis media after ossicular reconstruction with partial ossicular replacement prostheses and total ossicular replacement prostheses

OBJECTIVE: To examine hearing results in pediatric patients after ossicular reconstruction with partial ossicular replacement prostheses (PORPs) and total ossicular replacement prostheses (TORPs) in children with chronic otitis media. METHODS: A retrospective chart review was performed on 55 pediatric patients with chronic otitis media who underwent ossicular reconstruction from 1991 to 1998. Patients' audiograms were evaluated preoperatively and postoperatively for pure-tone average (PTA), air-bone gap (ABG), speech reception threshold (SRT), method of ossicular reconstruction, and management of the mastoid. RESULTS: Twenty-seven patients underwent ossicular reconstruction with TORPs. The average preoperative ABG was 40.1 dB, and the average postoperative ABG was 31.6 dB. Forty-one percent of the children improved their PTA greater than 10 dB postoperatively, and 52% of children did not change their ABG by more than 10 dB postoperatively. Nineteen percent of children with TORPs had a postoperative ABG less than 20 dB, and 44% of children with TORPs had a postoperative ABG less than 30 dB. Twenty-eight patients underwent ossicular reconstruction with PORPs. The average preoperative ABG was 29.7 dB, and the average postoperative ABG was 22.5 dB. Thirty-two percent of patients improved their PTA by greater than 10 dB, while 57% of children with PORPs did not change their ABG by more than 10 dB postoperatively. Forty-three percent of children with PORPs had an ABG of less than 20 dB postoperatively, and 71% of children with PORPs had a postoperative ABG less than or equal to 30 dB. CONCLUSIONS: Children who underwent ossicular reconstruction with PORPs had slightly better postoperative hearing than did children with TORPs. Postoperative hearing was essentially unchanged in approximately 55% of both groups. Preoperative hearing levels may be the most important factor determining postoperative hearing in nonstaged surgery for children with chronic otitis media Long-term hearing results in children with single-stage surgery were not as good as those reported in the literature for staged surgery. Severe mucosal disease and eustachian tube dysfunction may contribute to poorer hearing results in children.     

Results of ossicular chain reconstruction with glass ionomer cement in pediatric patients

ObjectiveThe aim of our study was to analyze the hearing results of ossicular chain reconstruction in incus long process defects in pediatric patients.MethodsThis retrospective study included 15 pediatric patients that had incus long process defect due to chronic otitis media or adhesive otitis, and repaired with glass ionomer cement between 2009 and 2015. The audiological tests (air conduction thresholds, bone conduction thresholds, air bone gap) obtained preoperatively and one year after surgery were compared. In addition, preoperative and postoperative air bone gap differences were estimated to determine hearing gain.ResultsMean air conduction and air bone gaps decreased significantly one year after surgery when compared to the preoperative values (p< 0.001 for both). Mean hearing gain was 20.33 ± 6.36 dB one year after surgery.ConclusionUse of glass ionomer cement to repair incus long process defects is a suitable method that improves hearing in pediatric patients. Further large studies that compare glass ionomer cement ossiculoplasty with other ossicular reconstruction methods are needed.     

乳突切开术并一期听骨链重建的临床疗效分析

目的：评估乳突切开术并一期行听骨链重建的临床疗效。方法：对2008-01～2011-06期间在我科住院行乳突切开术并一期钛人工听骨植入手术并且有完整随访资料的患者139例进行回顾分析,其中置入部分听骨赝复物（PORP）者91例,置入全听骨赝复物（TORP）者48例,随访时间为2～5年,纯音测听法（PTA）检测患者术前及术后听力,比较手术前后的气导听阈（0．5、1．0、2．0、4．0kHz四个频率气导之平均值）及气骨导差（ABG）,分析钛人工听骨在同期听骨链重建术的听力重建效果。术后ABG≤20dB为听力提高有效。结果：PORP植入患者术前气导平均听阈为（53．97±11．32）dB,术后为（36．80土11．68）dB,平均降低（17．17±5．79）dB;术前ABG平均为（31．84±6．17）dB,术后为（15．13±7．22）dB,平均缩小（16．71±5．50）dB;TORP组患者术前气导平均听阈为（58．05±11．35）dB,术后为（44．53±13．15）dB,平均降低（13．52±7．81）dB;术前ABG平均为（35．67±5．73）dB,术后为（21．48±7．01）dB,平均缩小（14．18±7．53）dB;各组术前术后的差异均有统计学意义（P〈O．01）。PORP组术后ABG≤20dB者（术后听力提高有效）共68例,有效率为74．73％;TORP组术后ABG≤20dB者共26例,有效率为54．13％;总有效率为68．63％,两组之间的差异有统计学意义（P＜0．05）。结论：乳突切开术并同期钛人工听骨植入取得了良好的听力效果,PORP比TORP的听力改善效果好。     

Technical refinements and precautions during ionomeric cement reconstruction of incus erosion during revision stapedectomy

OBJECTIVE: The study describes the technical precautions and short-term hearing results of fast-setting ionomeric cement (SerenoCem) for managing incus erosion in revision stapedectomy. STUDY DESIGN: Observational and retrospective chart review. METHODS: Consecutive patients undergoing ionomeric cement incus reconstruction during revision stapedectomy had surgery on an ambulatory basis in a tertiary care referral center. Main outcome measures included technical details, precautions, and recommendations for handling this new material and 6-week hearing outcomes comparing preoperative and postoperative air-conduction and bone-conduction thresholds. RESULTS: A small amount of ionomeric cement on the tip of otological picks applied to the incus remnant successfully reconstitutes the original length of the long process of the incus. In revision stapedectomy, a crimp-on prosthesis may be placed on the cement-lengthened incus. Six-week postoperative audiograms demonstrated significant closure of the air-bone gap in operated cases. Our experience in a failed case leads us to recommend that the setting time for the cement be increased to no less than 20 minutes as opposed to the manufacturer's recommendation of 10 minutes. Also, revision stapedectomy was more likely to be successful when the prosthesis was placed to the incus remnant and stabilized with cement, rather than placing the prosthesis on the cement itself. CONCLUSIONS: Ionomeric cement permits direct reconstruction of a pathologically shortened incus in revision stapedectomy. Surgeons must be aware of precaution and limitations of this new material. Preliminary results indicate significant hearing improvement with this technique when appropriate precautions are taken.     

Repair of a malleus-handle fracture using calcium phosphate bone cement

We report a case of a 60-year-old woman who reported a popping sound in her left ear, induced by changes in pressure, since she pulled her index finger out of her ear canal after accidentally inserting it while washing her hair. Otoscopic examination revealed a wrinkled tympanic membrane and irregular malleus handle. An isolated malleus-handle fracture resulting from barotrauma was suspected. The fracture was repaired surgically using calcium phosphate bone cement. Postoperatively, the problem disappeared and her hearing recovered. This case is the first to demonstrate the efficacy of calcium phosphate bone cement for repairing a malleus-handle fracture.     

Should ossicular reconstruction be staged following tympanomastoidectomy

OBJECTIVES: To determine whether ossicular reconstruction (OCR) performed concurrent with tympanomastoidectomy for cholesteatoma results in significantly different hearing results when compared to OCR performed in a separate, staged procedure. STUDY DESIGN: Retrospective. MATERIALS AND METHODS: Study subjects were patients undergoing OCR within a 2-year period. Intervention was OCR concurrent with tympanomastoidectomy for cholesteatoma (group 1) or staged following tympanomastoidectomy for cholesteatoma (group 2). Main outcome measures were mean postoperative air-bone gap (ABG), proportion achieving ABG closure to <20 dB and <30 dB for group 1 and group 2 overall and when controlling for type of mastoid cavity created (open or closed) and the status of the stapes suprastructure (TORP vs. PORP OCR). RESULTS: Eighty-three patients were identified. Forty underwent OCR concurrent with tympanomastoidectomy and 43 underwent a staged OCR after tympanomastoidectomy. Overall, similar hearing results were seen in the two groups. When considering the status of the stapes and mastoid cavity, concurrent OCR resulted in improved mean postoperative ABG in a closed mastoid cavity with an intact stapes suprastructure (P = .024). Furthermore, a greater proportion of patients who had concurrent OCR within this group achieved ABG <20 dB and ABG <30 dB, although this difference did not reach statistical significance (P = .092 and P = .078, respectively). By contrast, staged OCR resulted in improved mean postoperative ABG and ABG <30 dB in open mastoid cavities with an absent stapes suprastructure (P = .040, and P = .019, respectively). Similarly, a greater proportion achieved ABG <20 dB, approaching statistical significance (P = .055). CONCLUSIONS: Staged OCR is advantageous in those with most severe disease, whereas those with least severe disease may benefit from a concurrent OCR.     

耳内镜下听骨链重建探讨及初步疗效观察

目的探讨耳内镜下进行听骨链重建术的可行性。方法对1998年5月至2011年2月应用耳内镜(直径2.7mm,视角为0°或30°)行听骨链重建的52例病人进行回顾性分析,并对其近期疗效初步评估。结果 52例患者全部顺利在耳内镜下完成手术,其中耳硬化症25例,鼓室硬化症19例,听骨链部分缺损8例。耳硬化症患者4例采用镫骨底板部分切除,21例采用小窗技术,7例无需外道后上壁盾板切除,即可在内镜下完成手术。鼓室硬化症8例去除病灶行镫骨撼动,11例切除砧骨及镫骨上结构,采用TORP或Piston进行听骨链重建。听骨链部分缺损采用TORP或PORP人工听骨连接,重建听骨链。经随访6个月以上的病例有40例,其中35例术后听力有明显改善,骨气导差在15dB以内,近期疗效满意。结论根据初步临床应用观察,认为耳内镜可以用于听骨链重建手术,尤其是耳硬化症患者。其优点是创伤小,恢复快,缺点是耳内镜下进行单手精细操作有一定难度,对于外耳道狭窄者不适宜。     

A study on reconstruction of ossicular chain by an in situ bone tissue engineering technique

Conclusion. The acellular cancellous bone with recombinant bone morphogenetic proteins 2 (rhBMP-2) could induce osteogenesis in the acoustic vesicle; this material might be used to reconstruct defects of the ossicular chain. Objective. In recent years, the in situ tissue engineering technique has improved rapidly, especially in bone regeneration. The aim of this study was to make an ossicular prothesis using columnar acellular cancellous bone combined with rhBMP-2, implant this prosthesis into the acoustic vesicle of rabbits, and then observe the osteogenesis in situ. Materials and methods. We prepared the acellular cancellous bone combined with rhBMP-2 as an ossicular prothesis, while the same material without rhBMP-2 was used in the control group. From the retroauricular approach, we made a hole in the posterolateral bone wall of the acoustic vesicle, and the prepared materials were implanted. After 3 months, we observed the osteogenesis of the prothesis by macroscopic anatomic and histologic methods. Results. The rabbits recovered soon after surgery. The implanted acellular cancellous bones were connected tightly with the bone of the acoustic vesicle wall. The surfaces of all materials were covered with mucosa, and osteogenesis was observed in the material with rhBMP-2.     

Partial ossicular reconstruction in children: A review of 62 operations

Objective/Hypothesis: The published experience and audiometric results with ossicular reconstruction in children are limited. To better understand the role of ossiculoplasty in children, audiometric results were examined for partial ossicular reconstructions performed on a pediatric population. Study Design: Retrospective. Methods: Sixty-two partial ossicular reconstructions performed on a pediatric population were reviewed for audiometric results, prosthesis extrusion rates, and mechanisms of failure at revision. Comparison of techniques and prosthesis types: porous polyethylene partial ossicular replacement prosthesis (POP), Schuring ossicle cup (SOC), and modified Robinson prosthesis (MRP) were also evaluated. Follow-up ranged from 6 to 72 months. Results: Six-month hearing results showed postoperative air-bone gaps less than or equal to 20 dB in 77% of cases. Successful results at 1 and 2 years were retained in 66% and 63% of cases, respectively. Results for POPs at 1 and 2 years were 78% and 89%. Results for SOCs at 1 and 2 years were 61% and 55%. The overall extrusion rate was approximately 3%. Conclusions: These results compare favorably with those from other, mostly adult, studies. Comparison of prosthesis types revealed generally stable long-term results with few significant differences. Success with ossiculoplasty in children can be obtained by applying the same principles and approach to ossicular reconstruction as used in adults. Ossicular reconstruction in children remains a secondary goal after establishing a safe, dry, and stable ear. A discussion of techniques and comparative literature review are presented. Laryngoscope, 108:1674–1681, 1998     

听骨链修复与功能重建的理论与实践

旨在消除或缩小气骨导差的中耳重建技术起自20世纪初,Matte（1901）首先报道的鼓膜一镫骨连接技术（nlyringostapediopexy）被认为具有标志性意义,此后”j现了很多旨在建立鼓膜和内耳淋巴液间联系的方法。直到20世纪50年代,Zollner（1955）和Wullstein（1956）的工作使之成为公认的现代听骨重建技术的奠基者。与之相伴的外科技术以及材料科学的进步,使得中耳重建手术的效果逐步提高。虽可明品改善患者听力水平,但欲获得稳定的远期疗效仍面临许多问题。术后感染、局部粘连、排斥反应以及耳咽管功能障碍等成为影响效果的主要因素。     

Functional results of Plastipore prostheses for middle ear ossicular chain reconstruction.

OBJECTIVE: Assessment of plastipore prostheses for middle ear ossicular chain reconstruction. Hearing results with total and partial Plastipore ossicular replacement prostheses (TORP and PORP) were evaluated in open- and closed-cavity operations. STUDY DESIGN: A retrospective review of 237 patients who underwent operation for chronic ear disease as well as ossiculoplasty with plastipore prostheses. In order to assess the functional results, only 156 of 237 patients were included in the study. Follow-up ranged from 6 to 46 months. METHODS: Canal wall up and canal wall down operations were performed. Either TORP or PORP ossiculoplasty was performed in each operation. An airbone gap closure to within 20 dB was considered successful. RESULTS: With TORPs, the airbone gap closure to within 20 dB was achieved in 43.1%, and similar results were obtained with PORPs in 63.3%. In canal wall down and canal wall up operations, the success rates were 55.8% and 55.7%, respectively. The best results were obtained with PORPs in canal wall down operations, with a success rate of 82%. The extrusion rate of the prostheses was 4.2%. CONCLUSION: Hearing results of PORPs are better than TORPs. In canal wall up and canal wall down operations similar hearing results are obtained. PORP ossiculoplasty in a canal wall down operation yields the most favorable hearing result.     

Titanium ossicular chain reconstruction in single stage canal wall down tympanoplasty for chronic otitis media with mucosa defect

Purpose

To evaluate surgical outcomes for chronic otitis media with mucosa defect underwent titanium ossicular chain reconstruction (OCR) in single stage canal wall down tympanoplasty (CWD).

Ossiculoplasty with intact stapes: analysis of hearing results according to the middle ear risk index

Conclusions. In ossiculoplasty with intact stapes, using autologous incus, cortex bone chips and plastipore partial ossicular reconstruction prostheses, improvement in hearing was nearly equal. In patients who had mild risk scores, the incus had better gain values compared with patients who had severe scores. Objective. We aimed to prove the utility of the middle ear risk index score and its predictive value in hearing outcome. We also evaluated hearing results for different reconstruction materials. Patients and methods. This was a retrospective chart review of 189 patients who had ossiculoplasty with intact stapes using autologous incus, cortex bone chips and plastipore partial ossicular reconstruction prostheses. Hearing outcomes and the average improvement in hearing with different reconstruction materials were analysed by using middle ear risk index scores. Results. The average hearing improvements for incus, cortex and partial ossicular reconstruction prostheses were 12.77±14.58 (p<0.001), 12.34±15.98 (p=0.005) and 14.10±13.87 dB (p<0.001), respectively. The postoperative air–bone gap levels were 20.42±14.54 dB in incus, 17.33±16.86 dB in cortex and 17.59±11.66 dB in partial ossicular reconstruction prostheses. When the preoperative middle ear risk index scores and postoperative air–bone gap and gain values were compared, in the incus group, statistically significant associations were demonstrated between scores and hearing outcomes (p=0.009).     

Tympano-ossiculoplasty utilizing the Spiggle and Theis titanium total ossicular replacement prosthesis

OBJECTIVE: Since 1993, titanium prostheses have been used in Europe as a biocompatible implant for ossicular reconstruction. More recently, the titanium ossicular prosthesis has become more widely available in the United States as a newer means of surgical restoration of hearing. We will review the hearing results of patients who have undergone tympano-ossiculoplasty using a titanium total ossicular replacement prosthesis (TOP). We will compare these results to our previously published results using the porous polyethylene TOP. METHODS: Retrospective review in a tertiary otologic practice. RESULTS: Eighteen patients underwent tympano-ossiculoplasty with a titanium TOP. Among these patients, 10 cases involved revision of a previously placed ossicular prosthesis. Hearing results showed that 16 of 18 patients (89%) had closure of the postoperative air-bone gap to within 20 dB, and the average air-bone gap improvement was 23 dB. The average follow-up time was 8 months (range, 2-21 months). The results of this initial evaluation compare favorably with the results that we obtained using a porous polyethylene TOP in which 67% of 133 patients closed the air-bone gap to within 20 dB. CONCLUSION: We have recently begun using the titanium TOP, which has resulted in improved postoperative hearing when compared with the porous polyethylene TOP. In the future, longer follow-up and increased patient numbers will strengthen our conclusions.     

Biocompatibility of vitallium as ossicular reconstruction material in the middle ear: experimental animal study

Conclusion Although long-term data will be necessary for confirmation, the result of this preliminary study indicates that vitallium may be a good alternative material for ossicular replacement prostheses in the middle ear.

Objectives To investigate the biocompatibility of vitallium (Co–Cr–Mo) as ossicular reconstruction material in the rabbit middle ear, and to compare the results with those obtained with titanium, well known as a highly biocompatible material, and non-implanted control groups.

Material and methods Eighteen female New Zealand White rabbits were anesthetized. The tympanomeatal flap was elevated and 12 vitallium and 12 titanium implants were placed in the bulla away from the ossicles in 24 middle ears. Six rabbits were used as non-implanted controls. All animals were sacrificed under general anesthesia on the 180th day after implantation. The temporal bones were removed, fixed in 10% buffered paraformaldehyde and decalcified for a week in EDTA. Tissue samples were then prepared using an Autotechnicon and embedded in paraffin. Sections (30-μm thick) were cut with a microtome, stained with hematoxylin–eosin, von Gieson's stain and fibroblast growth factor (FGF) and examined under a light microscope. The numbers of lymphocytes, collagen fibers and FGF-positive cells were determined in all three groups.

Results There was no significant difference in the numbers of collagen fibers between the groups (p>0.05). No significant differences were found in the numbers of lymphocytes and FGF-positive cells between the titanium and vitallium groups (p>0.05). The differences in the numbers of lymphocytes and FGF-positive cells between the control and other groups were found to be significant (p<0.05).     

Repair of the ossicular chain with an ionomer cement by an inadequate incus after prior stapes surgery for otosclerosis

Use of an ionomer bone cement is described for repairing the ossicular middle ear system in revision stapes surgery. The cement was used to enlarge an eroded inadequate incus to allow placement of a new stapes prosthesis. Reconstruction of the incus with this new bone cement was readily performed and hearing results after 2 years of follow-up have been promising.