Comparative study of new autologous material, bone-cartilage composite graft, for ossiculoplasty with Polycel® and Titanium.

OBJECTIVE: Ossiculoplasty is a surgical procedure that recreates sound transmission of the middle ear in conductive hearing loss. Various materials have been used for ossicular reconstruction, but the most ideal material for ossiculoplasty remains controversial. The purpose of this study was to introduce a novel method of autologous ossiculoplasty, bone-cartilage composite graft (BCCG) and to compare its surgical results with different types of ossiculoplastic prostheses. STUDY DESIGN: A retrospective study was performed in a tertiary referral centre. METHODS: Data of 275 patients who received ossiculoplasty using the three different materials of BCCG, Polycel® and titanium were analysed according to type of ossiculoplasty: partial or total ossicular replacement prosthesis (PORP or TORP). Hearing results, complication rates and clinical parameters including age, sex, past history, preoperative diagnosis and surgery type were compared among different groups. RESULTS: Ossiculoplasty with BCCG showed satisfactory hearing outcomes and the lowest complication rate among the three different materials. In particular, its extrusion rate was 0%. CONCLUSION: We propose that the BCCG technique is a useful alternative method for ossiculoplasty, with proper patient selection.

Autologous incus versus titanium partial ossicular replacement prosthesis in reconstruction of Austin type A ossicular defects: a prospective randomised clinical trial.

OBJECTIVE: This study aimed to compare the functional and anatomical outcomes of ossiculoplasty using an autograft incus or a titanium partial ossicular replacement prosthesis for reconstructing Austin type A ossicular defects. METHODS: Patients with Austin A ossicular defects were randomly divided into two groups: one group underwent ossiculoplasty with an autologous incus (the autologous incus group) and the other underwent ossiculoplasty with a titanium partial ossicular replacement prosthesis (the titanium prosthesis group). Otoscopic examination and audiological assessment was done pre-operatively and at 3, 6 and 12 months post-operatively. RESULTS: A post-operative average air-bone gap closure of less than 20 dB was seen in 13 patients (65 per cent) in the autologous incus group and 7 (35 per cent) in the titanium prosthesis group. There were fewer post-operative complications in the autologous incus group (20 per cent) than in the titanium prosthesis group (45 per cent). CONCLUSION: Hearing outcomes and graft take up after ossiculoplasty were significantly better when an autologous incus rather than a titanium partial ossicular replacement prosthesis was used to reconstruct Austin type A ossicular defects. The major disadvantages of the titanium prosthesis were unpredictable results and more post-operative complications.

Titanium prosthesis or autologous incus for total ossicular reconstruction in the absence of the stapes suprastructure and presence of mobile footplate.

The purpose of this study was to compare the hearing results after total ossicular replacement with a titanium prosthesis or autologous incus in the absence of stapes suprastructure and presence of mobile footplate as a retrospective medical record review in a tertiary referral center setting. There were 49 patients who had total ossicular reconstruction (titanium prosthesis, 40 patients; autologous incus, 9 patients). Medical records were reviewed after total ossicular replacement. Air-bone gap at 1 and 2 years after surgery were determined with the 4-frequency average (0.5, 1, 2, and 4 kHz) and the American Academy of Otolaryngology-Head and Neck Surgery 4-frequency average (0.5, 1, 2, and 3 kHz). The number of patients who had air-bone gap <20 dB was determined. For comparisons that were based on American Academy of Otolaryngology-Head and Neck Surgery 4-frequency average, mean air-bone gap at 2 years after surgery was significantly smaller for the titanium prosthesis (21 dB) than autologous incus group (31 dB; P ≤ 0.03); the frequency of patients who had air-bone gap <20 dB at 1 or 2 years after surgery was significantly greater for the titanium prosthesis (1 year, 40%; 2 years, 56%) than autologous incus group [1 year, 0% (P ≤ 0.03); 2 years, 0% (P ≤ 0.04)]. Titanium prosthesis ossiculoplasty gave better results than autologous incus in the absence of the stapes suprastructure and presence of a mobile footplate.

Comparison of incus interpositioning technique versus glass ionomer cement application in type 2 tympanoplasty.

Objective of this study is to compare glass ionomer cement application and incus interpositioning techniques in patients who have chronic otitis media, conductive hearing loss with intact tympanic membrane and who undergo hearing reconstruction of staged surgery using a retrospective chart review in the setting of Ministry of Health Ankara Training and Research Hospital ENT Clinic, Turkey. We retrospectively evaluated patients who underwent otological surgery and hearing reconstruction with auto graft incus during 2005-2008 or glass ionomer cement during 2008-2010. Patients who had cholesteatoma, stapes fixation and tympanosclerosis were excluded. Postoperative mean follow-up time of 107 patients was 9.8 months (6-38 months, 83.2 % of them was ≤ 9 months). Postoperative pure tone hearing thresholds, graft status, gain scores and air bone gaps were recorded. Intact graft, dry ear on the operated side and ABG scores less than 20 dB were accepted as surgical success. Preoperative ABG score was 30.6 ± 7.93 dB in glass ionomer (group I) and 33.6 ± 11.99 dB in incus interpositioning (group II). Postoperative ABG scores were 13.6 ± 10.40 and 22.6 ± 12.39 dB, respectively, in group I and II. Success of closure in ABG scores was obtained in both groups (p < 0.001). Gain scores in group I were better (p = 0.035). Graft success (p = 0.020) correlated with gain score. Results showed that the glass ionomer cement application is a good, cost-effective technique, easy to perform and yields better hearing scores and lower complication rates compared to incus interpositioning technique.

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).

Malleus-stapes assembly: experience with two prostheses.

Tympanoplasty is often a necessary part of middle-ear surgery, the most common defect being that between an intact, mobile stapes and the malleus handle. The most readily available tissue is the patient's incus, reshaped to bridge the space between an intact stapes and the malleus. When the incus cannot be used, the hydroxyapatite Wehrs incus prosthesis can be used as an alternative.Twenty-six patients had an autograft incus ossiculoplasty and 20 patients underwent modified Wehrs incus prosthesis ossiculoplasty. The average post-operative air-bone gaps (ABGs) were 16.2 dB hearing loss (dBHL) and 17.2 dBHL, respectively. Air-bone gap closure to within 15 dBHL was achieved for 48 per cent of incus autografts and for 57 per cent of Wehrs prostheses, and to within 20 dBHL for 77 per cent and 62 per cent, respectively. Over four years follow up, the reconstruction was stable for each group, the ABGs being 17.7 dBHL and 17.1 dBHL, respectively.

[Ossicular reconstruction with autograft in type III]. / La réparation ossiculaire par autogreffe en type III.

OBJECTIVE: The prostheses known as biocompatible are usually proposed for columellar repair in absence of stapes but at which cost and which long-term tolerance? It appeared useful to study the possibilities of autograft ossicular reconstruction (incus and cortical bone) in absence of suprastructure of the stapes. MATERIAL AND METHODS: Retrospective study for 82 operated patients for cholesteatoma with lysis of the cruras of the stapes. Columellar repair was obtained by prosthesis, columella of cortical mastoid bone, and more often autograft of incus (54 cases). The technique of Autogreffe Tympanum-Cartilage-Os-Platinum (ATCOP) (Autograft Tympanum-Cartilage-Bone-Footplate is described: tympanic repair by fascia and cartilage from the concha is made at the first surgical step. Type III ossiculoplasty is performed at the second look. The distance tympanum-footplate is then lower than 6 mm and the body of the incus, preserved as a spare ossicle in the mastoid, has a sufficient length to be interposed in between new drum and footplate. RESULTS: 78% of the patients have final air bone gap less or equal than 30 decibels. The average post op air bone gap is 23 decibels with incus while it was 42 decibels before surgery. Average gain is 19 decibels. The cost of autograft is null and tolerance is excellent. CONCLUSION: Patient's incus is usable in type III ossiculoplasty thanks to a cartilage graft of the tympanic membrane. Patient's ossicle is a material of choice for columellar repair even in absence of the suprastructure of the stapes. Prostheses in biomaterial appear justified in case of absent or destroyed incus.

[Results after rebuilding the ossicular chain using the autogenous incus, ionomer-cement-and titanium implants (tympanoplasty type III)]. / Ergebnisse der Tympanoplastik Typ III mit autogenem Amboss sowie Ionomerzement- und Titanimplantaten.

BACKGROUND: A defective ossicular chain can reliably be reconstructed with standardized techniques using e. g. modern alloplastic materials. The comparison of clinical and functional results have proved its worth. Prospective clinical trial as well as collecting and evaluating relevant intraoperative and postoperative findings may be helpful to find the appropriate bone substitute in each case when rebuilding middle ear structures. METHOD: In 354 middle ears (332 patients) the defective or destroyed ossicular chain was rebuilt with the carefully trimmed autogenous incus (n = 83), with ionomer-cement implants (n = 100) and with titanium prostheses (n = 171). The follow-up of the earmicroscopic findings and middle ear function extended over a period of 1.5 years postoperatively on an average (min. 3 months, max. 6 years). The modified otologic record form named "Würzburger Ohrbogen" was used for preoperative and operative data, the "Ohrnachsorgebuch" for the postoperative follow-up. RESULTS: Using incus the air bone gap was improved up to 15 dB in the main speech area. Thus the average remaining conduction deficit was less than 10 dB. The "taking" of ionomer based cement prostheses and titanium prostheses was equally good. The cement implants showed a tendency to protrusion (n = 3), 2 titanium implants were extruded. The air bone gap decreased about 10 to 35 dB using titanium total prosthesis and about 15 to 20 dB using ionomer-cement total prosthesis. The remaining air bone gap with titanium implants was slightly less than with the ionomer-cement PORP (10-15 dB). The air bone gap using the titanium TORP was diminished in a reach of 10 to 35 dB, with the ionomer cement prosthesis between 15 to 20 dB. The remaining gap in the main speech area was slightly favorable to titanium (less than 15 dB) compared with the ionomer-cement TORP. Comparing higher frequencies the air bone gap of titanium was recognizable due to its light weight, but less impressive than expected. Revision surgery (n = 50) has to be performed by reason of cholesteatoma (n = 9), adhesive process (n = 8), dislocation of alloplastic prostheses (n = 8) and because of proposed "second look" (n = 14). CONCLUSIONS: Compared with other materials autogenous implants used for reconstruction of the incus have proved their value, however a deterioration of the sound transmission may develop in the long run. The middle ear compatibility of ionomer-cement implants is similar to titanium implants. The functional results of the titanium implants seem to be slightly superior.

[One-stage surgery of middle ear cholesteatoma in adults: apropos of 180 cases]. / Chirurgie en un temps du cholestéatome de l'oreille moyenne chez l'adulte: à propos de 180 cas.

OBJECTIVES: In order to evaluate the results of tympanoplasty in one stage middle ear cholesteatoma surgery, a retrospective study of 180 consecutive cholesteatomas operated on was undertaken. METHODS: 150 single procedures and 30 revision surgeries realized between 1992 and 1997 were analysed by studying anatomical and functional results with a mean follow-up of 24 months. RESULTS: Among the 150 adult patients, 85 (57%) were previously operated on in other centres and presented a recurrence of cholesteatoma. Closed technique was performed in 110 cases (61%) and opened one in the remaining cases (41%). Ossiculoplasty was made in 101 cases (56%) with different materials (15 incus autografts, 14 teflon prosthesis, 35 hydroxyapatite (HA) composite prosthesis and 37 all in HA prosthesis): 91 cases in a one-stage procedure but 10 worse functional results required a closed revision procedure. Twenty cases were also revised after one year of follow up at least: six recurrences of cholesteatoma were operated on by using canal down mastoidectomy (4%), 14 limited residual cholesteatomas (9.3%) had a revision closed technique procedure. CT Scan followed up all the patients operated on by a closed technique. Postoperative air-bone gap (ABG) was 20 +/- 11.3 dB and 27 +/- 10.1 dB in closed and opened techniques, respectively (p < 0.05). ABG was 20 +/- 9.2 dB and 26 +/- 13 dB in type II and type III tympanoplasty, respectively (p < 0.05). CONCLUSION: If the tympanic and posterior cavities are reasonably safe, middle ear cholesteatoma in adults can be well cured by a one-stage procedure including ossicular chain reconstruction with hydroxylapatite prosthesis covered with cartilage graft who achieved a valuable hearing restoration.

Incus interposition and ossiculoplasty with hydroxyapatite prostheses.

This article traces the evolution of transplant material in ossicular reconstruction of the middle ear. The first transplant consisted of the body and short process of the homograft incus. It was repositioned or wedged between the stapes head and the manubrium of the malleus. Further modification consisted of the sculpture of prostheses from homograft incudes; these were known as the notched incus with short or long process. By means of a notch in the short process, they were locked in place. The final phase is the use of hydroxyapatite as a biocompatible material from which similar prostheses may be precisely manufactured. These hydroxyapatite prostheses, known as the incus and incus-stapes replacement prosthesis, appear to be well tolerated and to produce excellent hearing results.

Histopathology of ossicular implants.

Ossicular and cortical bone grafts maintain their morphologic structure for long periods of time and show varying amounts of replacement of nonviable bone by new bone through a slow process of creeping substitution. Cartilage grafts develop chondromalacia, lose stiffness, and tend to be resorbed over time. Plastipore prostheses elicit foreign body giant cell responses with microscopic biodegradation of the implants. There is a great need for the study of well-documented human temporal bone cases with in situ ossicular implants.

[Homograft of incus in tympanoplasty]. / Tympanoplastyka homoprzeszczepem kowadelka.

Homograft of incus was applied for reconstruction of the ossicular chain in 34 patients. Two basic variations of plastics have been performed. The handle of malleus was supported by the body of the incus with the drilled hole, while the long process of the incus, after a little shortening, was put on the movable footplate of stapes. In the second variation the long process of the incus was amputated--here the drill hole was performed for the head of stapes and the second one in the body of the incus for the handle of malleus. In the average three years after the operation the good hearing results were achieved in 19 (55.9%) patients. From this group in 8 (23.5%) patients aerbone gap closure was at the level of 10 dB. The bad morphologic results was ascertained in 3 patients.

Hydroxylapatite ossicular replacement prostheses: results in 157 consecutive cases.

The use of hydroxylapatite for ossicular chain reconstruction is increasing. In this study, hearing results and extrusion rate for 157 consecutive patients receiving hydroxylapatite prostheses were evaluated. Results were compared to those of a control group of patients who had received either homograft bone or Plasti-Pore prostheses. Four (2.6%) cases of extrusion have occurred. Hearing success was defined as a postoperative puretone average air-bone gap of < or = 15 dB for incus prostheses and partial ossicular replacement prostheses (PORPs) or < or = 25 dB for incus-stapes prostheses and total ossicular reconstruction prostheses (TORPs). Overall success rate in the hydroxylapatite group was 51.4% for the 140 patients with postoperative data (mean follow-up, 11.5 months) and 46.7% for 90 patients who were followed for more than 6 months (mean follow-up, 16 months). PORP results were significantly poorer than those of the other prostheses. The success rate for the control group was 58.6% for 58 patients. The difference between hydroxylapatite and control group success rates appears to be due to the poorer results of the hydroxylapatite PORP.

Ossiculoplasty with the use of autografts and synthetic prosthetic materials: a comparison of results in 165 cases.

One hundred and sixty-five cases of different kind of ossiculoplasty in patients suffering from chronic middle ear disease were performed at the ENT department of Papanikolaou Hospital in Thessaloniki, Greece, during the years 1988-1990. There were 40 cases of incus transposition, 47 cases in which polyethylene TORPs and PORPs were used and 77 cases of hydroxylapatite prostheses (41 TORPs and 37 double notch PORPs). Hearing success was defined as a post-operative air-bone gap of < 20 dB. According to this criterion 74 per cent of the incus transposition cases were successful, 61 per cent of the polyethylene TORPs, 65 per cent of the hydroxylapatite TORPs, 40 per cent of the polyethylene TORPs, and 89 per cent of the double notch hydroxylapatite PORPs. It is obvious that ceramic PORPs produced the best results, while there was no statistical difference, regarding the hearing improvement, among the different kinds of TORPs which were used. Extrusion rate and other kinds of complications are also discussed, as well as a case of severely damaged ceramic TORP, within two years due to middle ear infection.

A five year follow up of incus transposition in relation to the first stage tympanoplasty technique.

This study was set up, prospectively, to determine factors affecting the long-term hearing results of patients undergoing incus transposition as a second stage in ossicular reconstruction, following a successful drumhead repair in non-cholesteatoma ears. Seventy-one patients were entered into the study over five years from 1980-1985, 66 were available to be studied throughout the five year follow-up period. Nine weeks post-operatively, 74 per cent of all patients has an air-bone gap of less than 15 dB (48/66). The type of first stage procedure had a significant effect on the hearing levels in the final five year assessment. The most successful sub-group were those patients who had a cortical mastoidectomy and silastic sheeting inserted in the first staging procedure. The air-bone gap, of less than 15 dB, was maintained in 71 per cent of this group (17/24). The sub-group who had a simple myringoplasty as the primary procedure had a good initial hearing level. By five years, however, only 30 per cent of the patients had maintained the air-bone gap of less than 30 dB (3/11).

Allograft stapes-incus assembly. Long-term results.

In 35 patients with absence of the stapedial arch, with a history of radical surgery, and without ossicles, the head of an allograft stapes was placed on the patients' footplates and an allograft incus body on the top of this. The long-term results of this assembly, judging by different methods of analysis, are still somewhat better than those of 98 ears with approximately the same pathologic condition treated by an allograft incus as the columella between the footplate and fascia. The allograft stapes-incus assembly is an alternative method to the commonly used incudal columella. The allograft stapes has not been resorbed to a significant degree during the years after surgery.

Transplanted ossicles after two decades.

The authors now report on the histological appearance of two very long-term ossicles, an autologous incus removed from the middle ear at revision surgery 21 years after repositioning and a homologous incus removed from the middle ear after 20 years. Having been placed in formalin immediately after removal from the ear, both specimens were later decalcified by ethylene diamine tetra-acetic acid, embedded in paraffin wax, serially sectioned and stained with haematoxylin and eosin.

[The hardness and osseous structure of preserved ear ossicles]. / Untersuchungen über die Festigkeit und knöcherne Struktur konservierter Gehörknöchelchen.

The mechanical rigidity (breaking strength) of normal human ossicles, preserved with cialit and formalin, was studied in a tension compression testing machine. The bony structure of the ossicles before and after crushing was examined via high-grade magnifying radiography. With this new technique, minute bony details of the ossicles, which up to now could be demonstrated only histologically--consequently destroying the object--can be visualised without inflicting any changes to the ossicle. The different preservation methods had no effect on the structure or the mechanical strength of the ossicles. The fracture lines were distributed at random, with no preferential direction. In further experiments, defects in the ossicles' surfaces, which were cut with diamond burrs, were investigated radiographically and with a scanning electron microscope. The compressed bone dust seals up the opened marrow spaces. This reduces bone resorption significantly, as could be demonstrated with removed ossicular transplants similarly prepared, with had been implanted several years ago. The high grade radiographic magnification revealed that several ossicles which were removed during typical middle ear operations, were covered with metallic powder, originating from the intra-operative contact of the burr with the metallic suction tube. The 10% nickel component of the alloy may cause problems in patients with known nickel allergy, considering the intensive contact with the vast surface of the disseminated metallic dust particles.

[Tympanoplasty with incus interposition]. / Tympanoplastik mit Ambossinterposition.

We report on a 5-year experience with 44 patients (1980-1985) with incus interposition using a modelled or sculptured incus, either autograft or homograft, to correct ossicular discontinuity when a functional malleus and stapes are present. After a period of 21 months, 75% of our patients achieved an air-bone gap closure between 1 and 10 dB. The postoperative hearing results of patients with trauma and middle ear atelectases were better than the hearing results of patients with cholesteatomas. These long-term results are dependent upon intact malleus attic ligaments and an intact tensor tympani tendon. It is very important that the modelled incus is repositioned under the malleus handle neck.

The versatility of presculptured homograft incus prostheses.

A twelve-year experience with banked homograft ossicles has developed into a system of presculptured incus allografts adapted for the correction of many ossicular defects encountered in tympanoplasty and revision stapes surgery. The standardized preparation of a number of variations of modeled incus prostheses for an operating room bank by a well-trained ear homograft laboratory technician has been an effective and time-saving technique.