Adverse Soft Tissue Reactions Research Articles

Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. Retrospective cohort study. Mean follow-up period of 3.8 years. Tertiary referral center. All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. Soft tissue reaction, implant survival, revision surgery, and BCD usage. In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). Single-center retrospective cohort study. Large general teaching hospital. A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

SAT245 Hips Don’t Lie: A Case Of Peri-Prosthetic Pseudotumor Leading To Hypercalcemia After Total Hip Replacement.

Abstract Disclosure: F. Sotomayor: None. H. Whitlatch: None. Background: Peri-prosthetic pseudotumors are well described, yet rare complications of total hip replacement. They can present as destructive or granulomatous lesions. We present the first documented case of 1,25 vitamin D-mediated severe hypercalcemia caused by a periprosthetic granuloma. Case: A 62-year-old man with a history of osteoporosis, ankylosing spondylitis presented with hypercalcemia (calcium 12.2 mg/dL) on routine laboratory testing. He had a history of bilateral cement hip arthroplasty in 1981 followed by multiple bilateral revisions - three revisions of left hip arthroplasty, one revision of right hip arthropasty. Biochemical evaluation included PTH 5 pg/mL (8 - 54 pg/mL), PTHrP 2.7 pmol/L (0.0 - 2.3 pmol/L), vitamin D-25 59 ng/mL (20-80 ng/mL), a negative Quantiferon TB Gold, and normal serum protein electrophoresis. 1,25 Vitamin D was elevated at 280.5 pg/mL (19.9-79.3 pg/mL). During investigation of 1,25 vitamin D-mediated hypercalcemia, he received a dose of zoledronic acid with transient improvement in hypercalcemia. ACE was negative and CT chest and abdomen was without evidence of granulomatous disease. A whole-body PET scan showed increased metabolic activity surrounding the right femoral and acetabular components with a broad zone of osteolysis in the proximal femur and increased metabolic activity surrounding the left greater trochanter. These findings were concerning for inflammatory granuloma formation. He was prescribed prednisone 30 mg daily with rapid normalization of serum calcium. Prednisone was gradually tapered to 10 mg daily with maintenance of normocalcemia. Discussion: Pseudotumors are an uncommon complication of total hip arthroplasty. These are described as non-infectious and non-neoplastic adverse soft tissue reactions to implants. They manifest as destructive or granulomatous periprosthetic lesion. They cause osteolysis, erosions, pathological fractures, and dislocations. Their formation is due to foreign body reaction to polyethylene, methylmethacrylate, cement or metal adjacent to the joint implant. Associated inflammation leads to macrophage activation, prostaglandin release, and osteolysis. Histologically, they are characterized by the presence of macrophages, extensive coagulation necrosis, lymphocytes, eosinophilic infiltration and granulomatous reaction. While non-malignant, they can cause extensive bony destruction and may require complex revision surgery. To date, this is the first reported case of hypercalcemia due to excess 1,25 vitamin D caused by a periprosthetic granuloma. Conclusion: Hypercalcemia is a well-described complication of granulomatous diseases, including sarcoidosis, mycobacterium infection, and lymphoma. In patients with a history of arthroplasty, we recommend adding peri-prosthetic pseudotumors to the differential diagnosis of 1,25 vitamin D mediated hypercalcemia. Presentation: Saturday, June 17, 2023

Evaluation of different designs for posterior cantilever zirconia inlay-retained fixed dental prostheses in missing tooth replacement: Stage one results with 18-month follow-up assessment

ObjectivesThis clinical study aimed to investigate the outcomes and survival rates of different variations of inlay-retained fixed dental prostheses (IR-FDPs) composed of monolithic zirconia ceramic. The IR-FDPs with a single-retainer design were used for replacing missing mandibular second premolars. The research evaluated the effectiveness and longevity of these prostheses in clinical settings. MethodsA total of 30 IR-FDPs (n = 30) were placed for 27 female patients who presented with missing mandibular second premolar teeth. For this study, the mandibular first molar was chosen as a retainer for the cantilever IR-FDPs and the study involved a random assignment of participants into three distinct groups, each comprising 10 individuals (n = 10). The criterion for the grouping was the retainer design: inlay ring (IR), lingual coverage (LC), and occlusal coverage (OC). The three groups included mesial inlay box with the same dimensions (3 mm height, 3 mm width and 2 mm depth). All IR-FDPs were manufactured using monolithic high translucent 3Y zirconia and the connector area to the cantilever pontic was adjusted to dimensions of 3 × 3 mm for all designs. The restorations were bonded using adhesive resin cement. The clinical and radiographic evaluations of the restorations were conducted for a duration of 18 months, following the modified FDI (World Dental Federation) criteria. ResultsThe restorations were observed in stage one for a period of 18 months. Only one restoration in group LC was debonded after 10 months and re-bonded. The clinical quality of all crowns and the patient's satisfaction were high. No adverse soft tissue reactions around the crowns were observed and only one abutment in group IR was endodontically treated after 12 months. ConclusionsZirconia cantilever IR-FDPs offer a viable short-term treatment option for replacing missing posterior teeth, providing esthetic and functional benefits while minimizing invasiveness. Over an 18-month observation period, these prostheses have demonstrated a remarkable survival rate of 100% and a success rate of 96.6%. These findings suggest the effectiveness and reliability of zirconia cantilever IR-FDPs as a short-term solution for replacing missing posterior teeth. Clinical significanceZirconia cantilever IR-FDPs could present a practical solution for addressing posterior tooth loss, especially in cases where implant placement is not recommended and conventional fixed dental prostheses entail excessive invasiveness.

Three-year clinical evaluation of zirconia and zirconia-reinforced lithium silicate crowns with minimally invasive vertical preparation technique

ObjectivesLarge part of the tooth is required to be removed during crown preparation. A minimally invasive method for preparing single crowns is required to increase the durability of teeth. The aim of this study was to evaluate the clinical performance of two ceramic systems fabricated with minimally invasive vertical preparation.Materials and methodsForty endodontically treated maxillary premolars were prepared with vertical preparation and received temporary crowns for a period of 21 days. Twenty zirconia-reinforced lithium silicate (Celtra Duo HT, Dentsply Sirona, Germany) and 20 monolithic high translucency zirconia (Katana HT, Kuarary Noritake, Japan) crowns were fabricated by CAD/CAM and cemented with dual-polymerizing luting resin. The crowns were evaluated clinically and radiographically for 36 months following modified FDI criteria. Statistical analysis was conducted with t Student test (Cochran Q).ResultsOver the follow-up period, there was no need to replace any of the study’s crowns. The overall survival rate of the 40 crowns was 100% according to the Kaplan–Meier survival method. The clinical quality of all crowns and the patient’s satisfaction were high. No caries was detected and no adverse soft tissue reactions around the crowns were observed. Periodontal probing depth was reported to be increased at mesial and distal sites more than the facial one in the 36-month follow-up with no statistically significant difference between both materials (P = 0.186).ConclusionsZirconia and zirconia-reinforced lithium silicate could be used as a material for restoration of teeth prepared with vertical preparation technique. Both ceramic materials achieved good esthetic results, promotes healthy and stable soft tissues with no mechanical complications after 3 years of clinical evaluation.Clinical relevanceMonolithic high translucency zirconia and zirconia-reinforced lithium silicate ceramics can be used for the restorations of minimal invasive vertical preparation in premolar area with 0.5 mm margin thickness.

The Computational Approach to Predicting Wear: Comparison of Wear Performance of CFR-PEEK and XLPE Liners in Total Hip Replacement

Wear on articulating bearing surfaces is a key factor causing revision in total hip replacement (THR). Wear debris that releases particles from bearing surfaces might result in adverse soft tissue reactions requiring revision surgeries. In this study, a comprehensive computational wear model based on the Archard wear equation was performed to investigate the wear performance under a three-dimensional (3D) physiological gait cycle, mimicking a normal walking condition (5 million cycles). The study shows that the accuracy of the model is highly dependent on the mesh convergence, the wear fraction, and the scaling factor. The simulations were run to provide a vast amount of detail for the reproducibility of the work. Cobalt chromium (CoCr) on cross-linked polyethylene (XLPE) and CoCr on carbon-fiber-reinforced polyether ether ketone (CFR-PEEK) prototype models were created in silico. The volumetric wear rates for CoCr-on-XLPE were calculated as 0.2989 for CoCr head and 21.0271 for XLPE liner, while for CoCr-on-CFR-PEEK they were 0.3484 for CoCr head and 1.8476 for CFR-PEEK liner. When compared to in vivo and in vitro studies, the wear patterns of these two prototypes are consistent with those of the conventional polyethylene liners in the literature. Although the volumetric wear rate of the CFR-PEEK liner is about 11 times lower than the counterpart of XLPE in MoP implants, the wear rate of CoCr was higher when compared to its use with XLPE. Therefore, CFR-PEEK articulating against orthopa\\edic metals may not be as good an alternative as XLPE, due to higher indicative metallic wear. This detailed computational wear modeling methodology could be utilized in design improvements of implants.

Determination of Incidence of Soft Tissue Reactions after Total Hip Replacement using Elastography and Role of Elastography in Screening of Periprosthetic Soft Tissue: A Prospective Observational Study

Introduction: Adverse local tissue reactions after Total Hip Replacement (THR) have been widely described in literature recently as a course of aseptic loosening. Evaluation for any adverse soft tissue reactions is challenging with traditional imaging techniques like Magnetic Resonance Imaging (MRI), and are limited, due to production of metallic artifact. Ultrasound, specifically its refined form elastography, has emerged recently as a useful tool for assessing the soft tissues. Aim: To determine the incidence of soft tissue reactions in cases of THR and to evaluate role of elastography in assessment of periprosthetic soft tissue. Materials and Methods: This prospective observational study was conducted in the Department of Orthopaedics, Dr. Hardas Singh Orthopaedic Hospital, Amritsar, Punjab, India, from May 2013 to April 2014. Study comprises of consecutively followedup 66 hips which were evaluated and assessed clinically and radiologically using ultrasound elastography for periprosthetic soft tissue and degree of fibrosis. The MRI was done in patients with positive findings only. Diagnosis was then confirmed with biopsy in patients who underwent revision surgery. Incidence of clinical symptoms, implant loosening, stability of implant, various types of soft tissue reactions, pseudotumour formation and synovial hypertrophy were determined and association between clinical and radiological findings was done. Chi-square test was determined to see the statistical significance. Results: Total of 66 hips were studied in 60 patients with mean age of 56.08±16.55 years (26-95 years). The incidence of soft tissue reactions observed in the study was 83.3% (n=55), of all 66 hips 36 were symptomatic, Implant loosening was seen in 29 hips, pseudotumours were detected in 3 (4.5%) hips, cystic nodules in 2 (3.0%) hips, enlarged lymph nodes in one (1.5%) hip, fibrogranuloma in 2 (3%) hips and synovial thickening was seen in 12 hips. Association of Harris Hip Score with capsular thickness, implant stability and acetabular loosening was found to be statistically significant. Conclusion: The study shows a substantially higher incidence of soft tissue reaction and capsular hypertrophy following THR. Ultrasound elastography is a good screening tool to detect early soft tissue changes in periprosthetic tissue.

TZNT alloy for surgical implant applications: A Systematic Review

Nowadays, Ti–Nb–Ta–Zr (TZNT) alloy have attracted attention as new titanium alloy material for surgical implant applications due to its biocompatibility, great corrosion behavior, low cytotoxicity, and enhanced wear resistance, biological and mechanical properties. There is a great need to improve the implant properties which can be achieved through a combined solution of titanium alloy (TNZT) with low elastic modulus in the physiological environment of the body. Moreover, it protects the surgical implant from inflammation, infection, adverse soft tissue reaction to particulate debris and implant fracture. Therefore this review aimed to improve the quality of the surgical implant applications to enhance the working life and prevent failure by adding four matrices containing niobium, zirconium, tantalum, and silicon. Hence, TZNT alloy can be developed to be a promising candidate for biomedical applications especially in surgical implant applications.

Six-Month Clinical Outcomes for Bone-Anchored Hearing Implants: Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.

The aim of this study is to investigate and compare the clinical outcomes of minimally invasive ponto surgery (MIPS) to the linear incision technique with soft tissue preservation (LIT-TP) for percutaneous bone-anchored hearing implants (BAHI). Prospective cohort study with a historical control group. Tertiary referral center. Twenty-five patients were prospectively included in the test group. The control group consisted of 25 patients who previously participated in another clinical trial and already underwent BAHI surgery. All patients were implanted with a 4.5-mm-wide implant, using MIPS in the test group and the LIT-TP in the control group. Follow-up visits were scheduled 7 days, 21 days (sound processor fitting), 12 weeks and 6 months after surgery. The primary outcome measure was skin sensibility around the abutment 6 months after surgery. Secondary outcomes were subjective numbness, surgery time, wound healing, adverse soft tissue reactions, cosmetic outcomes, implant stability quotient (ISQ), implant survival, and sound processor use. Skin sensibility, adverse soft tissue reactions, and sound processor use were comparable between groups. The test group had a shorter surgery time and better cosmetic outcomes. More skin dehiscences and a statistically nonsignificant higher implant loss rate (12% vs 0%, p = 0.079) were observed in the test group. MIPS is comparable to the LIT-TP regarding skin sensibility at 6 months and soft tissue tolerability. With MIPS, surgery time is further reduced and better cosmetic outcomes are reported. More research into MIPS, exact drill protocol, used instruments, and associated implant loss is warranted.

The use of the RegJoint™ implant for base of thumb osteoarthritis: Results with a minimum follow-up of 2 years

The RegJoint™ (Scaffdex Oy, Finland) implant is a bio-absorbable poly-L/D-lactide implant which acts as a temporary support in resected joint spaces. It can be used in base of thumb surgery as a spacer to prevent first metacarpal subsidence. However, high rates of adverse tissue reactions and bone osteolysis have been reported recently by one group. The objective of this study was to investigate the outcome of patients treated in our institution with this implant. Patients underwent a postoperative clinical and radiological assessment. The QuickDASH questionnaire, Patient Evaluation Measure (PEM) and a visual analogue scale for pain assessment were used. Grip strength, key pinch, pinch strength, thumb palmar and radial abduction and opposition were measured. Trapeziometacarpal height was used to evaluate thumb shortening compared with the preoperative value. Periprosthetic bone-erosion of the trapezium and metacarpal were measured. Subluxation of the joint was evaluated by measuring the step-off between the radial edge of the trapezium and the base of the first metacarpal bone. Twenty-two patients from 2013–2016 were included. There were no postoperative wound complications. There was no significant difference in grip strength, key pinch or pinch between the operated and the contralateral hand. There was no significant difference in the trapeziometacarpal height, trapezial height or the degree of subluxation pre-or post-operatively. Contrary to recent reports, we did not find any adverse soft tissue reactions or significant bone erosion. There was no significant change in hand function. We consider the RegJoint™ a useful adjunct in the management of a select cohort of patients with base of thumb arthritis.

Validation of revision data for total hip and knee replacements undertaken at a high volume orthopaedic centre against data held on the National Joint Registry

BackgroundWith over 2.35 million records, the National Joint Registry (NJR) is the largest arthroplasty registry in the world. It provides a powerful tool to monitor implant survivorship and influence different surgical strategies. To date, little work has been undertaken to investigate the validity of the ‘Reason for Revision’ recorded in Consultant Outcome Reports on the NJR.MethodsThe NJR was queried to identify all revisions on the THR performed at a single centre over an 11-year period. Review and validation of ‘Reason for Revision’ for each case was undertaken using radiological imaging studies, pathology, histology, microbiology and electronic medical records.ResultsOf the 22,046 primary total hip replacements (THR) and total knee replacements (TKR) undertaken by 23 surgeons at our hospital, over an 11-year period, 1.35% (297) were subsequently reported to the NJR as revised. Discrepancies in reporting to the NJR were identified for 41 cases (25.63%) for THR and 28 (20.40%) cases for TKR. Revision for infection was under-reported for both THR and TKR by 1.88% and 3.65% respectively. Reporting of adverse soft tissue reaction to particulate debris for THR was unreported by 11%. Progressive arthritis following a TKR was unreported by 6.56%. All the cases reported as ‘other’ (8.75% for THRs and 3.65% for TKRs) were reclassified to the most appropriate ‘reason for revision’ category. The ‘reason for revision’ data is recorded to the NJR with findings at the time of surgery. It is some days before microbiology and histology reports become available and source data is not always updated.ConclusionIf an average of 23% wrong data entry at a highly organised institution is replicated throughout the UK, a formal process to validate primary and revision data submitted to the NJR should be considered. Local scrutiny, review and validation of revision data are all vital to optimise the value of the NJR. Accurate data recorded to the NJR is imperative to provide safe and effective improvements in orthopaedic surgery.

Midterm outcomes of total hip arthroplasty with a modular Birmingham head.

Birmingham Hip Resurfacing (BHR) implants may be combined with a conventional femoral stem to create a modular metal-on-metal total hip arthroplasty (BHR MoM THA). There is little outcome data regarding this construct. This study examines midterm outcomes of BHR MoM THA compared to oxidised zirconium total hip arthroplasty (THA). A retrospective institutional review identified all patients receiving BHR MoM THA between April 2005 and February 2011 and a matched control cohort of zirconium THA patients. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), and SF-12 Health status scores were obtained. Revisions and complications were collected from clinical records. Radiographs were assessed for evidence of component malposition, loosening, osteolysis, or heterotopic ossification. 63 modular BHR MoM THA were identified in 61 patients (36 with BHR cups, 27 with R3 cups) and 63 zirconium THA in 58 matched controls. Mean follow-up was 58 months. 14 BHR MoM THA hips (22.2%) were revised (4 infections, 1 dislocation, 9 soft tissue reactions) compared to 3 (4.8%) zirconium THA (all infections). At latest follow-up, 18.4% of surviving BHR MoM THA hips were painful compared to 0.5% of zirconium THA controls (p < 0.001). WOMAC, HHS, and SF-12 did not differ significantly between surviving members of the 2 groups. BHR MoM THA demonstrated a high revision rate, largely for adverse local soft tissue reaction and pain. Among those not revised, many reported some residual pain despite similar quality of life measures to those who received zirconium THA.

Creating an antibacterial surface on beta TNZT alloys for hip implant applications by laser nitriding

The National Joint Registry reported that the main causes for hip implant revision surgery include aseptic loosening, infection and adverse soft tissue reaction to particulate debris. There is a great need to improve the implant properties which can be achieved through a combined solution of beta titanium alloy (TNZT) with low elastic modulus and laser surface nitriding to improve mechanical properties and biological response. While titanium nitride (TiN) possesses good biocompatibility and remarkable antibacterial properties; its effectiveness as a coating on Ti-35Nb-7Zr-6Ta has not been investigated in relation to stem cell response and antibacterial capability. TNZT surfaces were laser-nitrided in incremental laser power, specifically 35, 40 and 45 W. Investigation included surface roughness and topography in microscale (WLI and SEM), microstructure (XRD) and wettability (water contact angle). Biological studies of the laser-nitrided surfaces included in vitro culture for 24 h using mesenchymal stem cell (MSC) fluorescence staining and Staphylococcus aureus (S. aureus) Live/Dead staining. Sample groups consisted of control base metal (BM), laser-nitrided at 35 W (LT35), 40 W (LT40) and 45 W (LT45). Results revealed that laser nitriding generates significantly rougher surfaces (Ra value of BM was 199.3 nm, LT35 was 722.8 nm, LT40 was 458.4 nm and LT45 was 1180.2 nm) with distinctive surface features (Rsk < 0 and Rku > 3). Surfaces after laser nitriding, regardless of laser power, can be tailored to become hydrophilic (27.1–34.2°). Fibre laser nitriding can be used to create antibacterial surface patterns on TNZT in a high power regime. A laser power of 45 W proved to be the most effective in this study, creating an overlapping crescent shape which becomes more obvious with increasing power. To summarise, laser-nitrided surfaces led to a significant antibacterial effect but offered no particular advantage to MSC response.

Radiographic evaluation of hip resurfacing: the role of x-rays in the diagnosis of a problematic resurfaced hip.

Hip resurfacing (HRA) requires a new standardised radiographic evaluation protocol. Evaluation of acetabular components is similar to total hip arthroplasty (THA) but femoral components require different criteria. This study evaluates the efficacy of a new femoral zonal system for radiographic HRA assessment in identifying clinical problems. A new proximal femoral zonal system divides implant-cement-bone interfaces at head and neck into 7 DeSmet zones. 611 in situ and 100 revised HRA were assessed for component positioning, borderline findings (reactive lines, cortical thickening, cancellous condensation) or sinister findings (lucent lines, bone resorption, osteolysis). Findings were correlated with gender, size, implant survival, clinical scores, metal ions, and adverse soft tissue reactions (ALTR). Radiological changes were found in 265 hips (37.3%), 154 sinister (21.7%) and 111 borderline (15.6%). 84% of revisions had sinister findings versus 11.4% of in situ HRA (p < 0.001). The mean number of abnormal acetabular and femoral zones was 3.3 in revised compared to 0.6 in situ HRA (p < 0.001). Sinister findings were associated with female gender, lower clinical scores, smaller sizes or ASR design (all: p < 0.001). Metal ions were higher with sinister (p < 0.001) and borderline (p < 0.01) findings compared to normal radiographs. Pathological findings in ⩾4 zones had a sensitivity of 50% and specificity of 94.2% (AUC = 0.898) in detecting hips with ALTR (odds ratio = 49). In order to accurately evaluate progressive radiographic changes in HRA, specific zones have been established around the femoral component. There was a high correlation between radiographic findings and outcome measures. 84% of problematic hips and 90.4% of proven ALTR had sinister changes.

Percutaneous bone-anchored hearing implant surgery: linear incision technique with tissue preservation versus linear incision technique with tissue reduction.

To identify differences in skin thickening and soft tissue reactions between the linear incision technique with tissue reduction (LITT-R) and the linear incision technique with tissue preservation (LITT-P). Retrospective cohort study. All adult patients who underwent the LITT-R or LITT-P between August 2005 and December 2016 at a large general teaching hospital with a minimum follow-up of 6months were included. A total of 83 implants were included using the LITT-R with a median follow-up of 74.0months. In the LITT-P cohort 58 implants were included with a median follow-up of 16.5months. Skin thickening was seen in seven implants (8.4%) in LITT-R cohort and 11 implants (19.0%) in the LITT-P cohort in the first 2years of follow-up (p = 0.024). Skin thickening in need of treatment was registered in 5 (6.0%), respectively, 6 (10.3%) implants (p = 0.100). Moreover, treatment was successful in all cases. A soft tissue reaction (Holgers ≥ 1) was noticed in 28 (33.7%) implants in the LITT-R group compared to 16 implants (27.6%) in the LITT-P group (p = 0.679). An adverse soft tissue reaction (Holgers ≥ 2) was registered in 16 (19.2%), respectively, 2 (3.4%) implants. This difference was significant (p = 0.040). LITT-P has a significantly higher rate of skin thickening and LITT-R has a significantly higher proportion of adverse soft tissue reactions. Nevertheless, combined with the advantages of LITT-P described in other studies, this can be advocated as the preferred technique.

Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing.

Objective:To compare 3-year implant stability, survival, and tolerability of a 4.5-mm-wide (test) and a 3.75-mm-wide (control) percutaneous titanium implant for bone-conduction hearing, loaded with the sound processor after 3 weeks.Methods:Sixty implants were allocated in a 2:1 ratio (test-control) in 57 adult patients included in this prospective randomized controlled clinical trial. Follow-up visits were performed at 7, 14, 21, and 28 days; 6 and 12 weeks; 6 months; and at 1, 2, and 3 years after implantation. During these visits, the implant stability quotient (ISQ) was measured by means of resonance frequency analysis (RFA). The peri-abutment soft tissue status was assessed according to the Holgers classification. Skin height around the abutment was evaluated.Results:The mean area-under-the-curve (AUC) of ISQ-low was statistically significantly higher for the test implant (65.7 versus 61.4, p = 0.0002). Both implants showed high survival rates (97.4% versus 95.0%, p = 0.6374). Adverse soft tissue reactions were observed sporadically, with no significant inter-group differences. Skin thickening was seen in the majority of the patients, but no correlation with adverse soft tissue reactions or implant type was observed.Conclusion:The 4.5-mm-wide implant provides significantly higher ISQ values during the first 3 years after surgery compared with the previous generation 3.75-mm-wide implant. Both implants showed high survival rates and good tolerability. These long-term results indicate that the wider implant, loaded with a sound processor at 3 weeks, is a safe and well-performing option for hearing rehabilitation in specific types of hearing loss.

Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.

Objective:To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years.Study Design:Single follow-up visit of a previously completed multicenter, randomized, controlled trial.Patients:Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial.Results:The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p < 0.0001] and control group +2.25 [SD ±4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%.Conclusion:The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.

Percutaneous bone-anchored hearing implant surgery: dermatome versus linear incision technique

The objective of this historical cohort study is to identify if there are differences in soft tissue reactions and skin thickening between implantation of the percutaneous bone-anchored hearing implant (BAHI) using the dermatome or linear incision technique. All adult patients who received a BAHI between August 2005 and January 2013 were selected. One surgeon performed all procedures and only the dermatome and linear incision technique were used. A total of 132 patients/implants were included and significantly more patients with risk factors were seen in the linear incision cohort. A soft tissue reaction Holgers ≥1 was present in 18 patients (40.9 %) in the dermatome compared to 36 patients (40.9 %) in the linear incision group. A Holgers ≥2 was noticed in 9 (20.5 %) and 19 (21.6 %) patients, respectively. Skin thickening was described in 14 (31.8 %) and 11 patients (12.5 %) in, respectively, the dermatome and linear incision cohort, which was a significant difference (p = 0.001). Nevertheless, therapeutic interventions were effective. In conclusion, there was no significant difference in (adverse) soft tissue reactions; however, skin thickening was more present in the dermatome technique. In addition, significantly more patients with risk factors were allocated to the linear incision technique. Based on these results, the linear incision is advocated as preferred technique.

Percutaneous bone-anchored hearing implant surgery: inside or outside the line of incision?

The objective of this historical cohort study was to compare soft tissue reactions in adults after bone-anchored hearing implant (BAHI) surgery when the percutaneous implant is placed inside or outside the line of incision. All adult patients who received a percutaneous BAHI between 1 January 2010 and 31 January 2014 in our tertiary referral centre were identified. Patients were selected if operated by two surgeons, who perform the same standardised linear incision technique with one of them placing the implant outside the incision while the other prefers placement inside the line of incision. A total of 202 patients and 211 implants were included in the case analysis. The results showed the registration of a soft tissue reaction Holgers ≥1 in 47 implants (49.0 %) placed outside the incision compared to 70 implants (60.9 %) which were placed inside the line of incision. An adverse soft tissue reaction, Holgers ≥2, was noticed in 17 implants (17.7 %), respectively, 20 implants (17.4 %). No significant differences were found between the two groups for both the presence of soft tissue reactions Holgers ≥1 (p = 0.322) and a Holgers score ≥2 (p = 0.951). During the follow-up three implants were lost (1.4 %) and in 18 of 211 implants one or multiple revisions were performed (8.5 %). In conclusion, this study did not show any differences in the presence of postsurgical (adverse) soft tissue reactions between placement of the percutaneous BAHI inside or outside the line of incision.

Cobalt serum levels differ in well functioning Birmingham resurfacing and Birmingham modular THA.

Metal-on-metal (MoM) bearings are known to release metal ions secondary to wear and corrosion. This may cause local reactions (adverse soft tissue reactions and osteolysis) and systemic effects. Little is known about the exact pattern and the differences between large head MoM total hip replacements (THA) and resurfacings (HR). (1) Is there a difference in metal ion concentrations between HR and MoM-THR using the same bearing design (Birmingham Hip Resurfacing System, Smith & Nephew, Inc. Memphis, TN, USA)? (2) Are metal ion levels changing over time in MoM-THA or HR? (3) Do acetabular inclination angle and femoral component size influence cobalt and chromium levels? Is there a correlation between clinical outcome and metal ion levels? A retrospective analysis was conducted in 77 well functioning unilateral Birmingham HR and 42 well functioning unilateral modular Birmingham MoM-THA (Smith & Nephew, Inc. Memphis, TN, USA) operated on between 2007 and 2012. Blood samples were taken at a minimum of 13months and subsequent during annual follow-ups. (1) Cobalt levels were significantly higher in MoM-THA compared to HR (p<0.001). There was no significant difference in chromium levels (p=0.313). (2) Cobalt is increasing over time in MoM-THA (p=0.030) whereas metal ions remain stable in HR. (3) Metal ion levels were not affected by acetabular inclination angle and femoral component size in MoM-THA. Chromium levels correlate with the femoral component size (r=-0.240; p=0.037), the UCLA activity score (r=-0.344; p=0.003) and the VAS (r=0.263; p=0.38) in HR. Considering that HR and MoM-THA used the same MoM bearing design, increased cobalt levels may be related to trunnion wear or corrosion. Elevated cobalt levels should raise concern for corrosion related failure in MoM-THA.