Staged implantation of active transcutaneous bone conduction hearing devices (BCHD) after explantation of older generation bone anchored hearing aids (BAHAs): Surgical outcomes and approach to management.

PURPOSE: To evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. MATERIALS AND METHODS: Retrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. RESULTS: Reasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2-8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. CONCLUSION: The transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.

The influence of prosthetic suspension on gait and cortical modulations is persons with a transfemoral amputation: socket-suspended versus bone-anchored prosthesis.

BACKGROUND: Persons with a transfemoral amputation (TFA) often experience difficulties in daily-life ambulation, including an asymmetrical and less stable gait pattern and a greater cognitive demand of walking. However, it remains unclear whether this is effected by the prosthetic suspension, as eliminating the non-rigid prosthetic connection may influence stability and cortical activity during walking. Spatiotemporal and stability-related gait parameters, as well as cortical activity during walking, were evaluated between highly active individuals (MFC-level K3-4) with a TFA and able-bodied (AB) persons, and between persons with a bone-anchored prosthesis (BAP) and those with a socket-suspended prosthesis (SSP). METHODS: 18 AB persons and 20 persons with a unilateral TFA (10 BAP-users, 10 SSP-users) walked on a treadmill at their preferred speed. Spatiotemporal and margin of stability parameters were extracted from three-dimensional movement recordings. In addition, 126-channel electroencephalogram (EEG) was recorded. Brain-related activity from several cortical areas was isolated using independent component analysis. Source-level data were divided into gait cycles and subjected to time-frequency analysis to determine gait-cycle dependent modulations of cortical activity. RESULTS: Persons with TFA walked with smaller and wider steps and with greater variability in mediolateral foot placement than AB subjects; no significant differences were found between BAP- and SSP-users. The EEG analysis yielded four cortical clusters in frontal, central (both hemispheres), and parietal areas. No statistically significant between-group differences were found in the mean power over the entire gait cycle. The event-related spectral perturbation maps revealed differences in power modulations (theta, alpha, and beta bands) between TFA and AB groups, and between BAP- and SSP-users, with largest differences observed around heel strike of either leg. CONCLUSIONS: The anticipated differences in gait parameters in persons with TFA were confirmed, however no significant effect of the fixed suspension of a BAP was found. The preliminary EEG findings may indicate more active monitoring and control of stability in persons with TFA, which appeared to be timed differently in SSP than in BAP-users. Future studies may focus on walking tasks that challenge stability to further investigate differences related to prosthetic suspension.

Bone-anchored prostheses for lower limb amputation in a French cohort with 1-15 years of follow-up: implant survival rates, mechanical complications, and reported outcomes.

PURPOSE: To evaluate the implant survival rate, mechanical complications, and reported patient outcomes of bone-anchored prostheses for patients with lower limb amputation in France after 1-15 years of follow-up. METHODS: This retrospective cohort study included patients who underwent surgery at a single center in France between 2007 and 2021. The primary outcomes were the implant survival rate and functional scores assessed by the Questionnaire for Transfemoral Amputees (Q-TFA). Secondary outcomes were adverse events that occurred during follow-up. RESULTS: The cohort consisted of 20 bone-anchored prostheses in 17 patients. The main level of amputation was transfemoral (82%, n = 14). The main reason for amputation was trauma (n = 15). The mean age at amputation was 32 (range 15-54) years, and the mean age at the first stage of osseointegration was 41 (range 21-58) years. The Kaplan-Meier survival curve showed respective survival rates of 90%, 70%, and 60% at 2, 10, and 15 years. All Q-TFA scores were significantly improved at last the follow-up. Eleven patients (65%) experienced mechanical complications. In total, 37 infectious events occurred in 13 patients (76%), mainly comprising stage 1 infections (68%, n = 25). Only two cases of septic loosening occurred (12%), leading to implant removal. CONCLUSION: This is the first French cohort of bone-anchored prostheses and among the series with the longest follow-up periods. The findings indicate that bone-anchored prostheses are safe and reliable for amputee patients who have difficulties with classic prostheses.

Survival of osseointegrated implants in head and neck cancer patients submitted to multimodal treatment: a systematic review and meta-analysis.

PURPOSE: To investigate the survival rate in implants placement in irradiated and non-irradiated bone in patients undergoing head and neck cancer (HNC) treatment. We focused on the consequences of the main complications, such as osteoradionecrosis and peri-implantitis. METHODS: An electronic search conducted by PRISMA protocol was performed. Full texts were carefully assessed, and data were assimilated into a tabular form for discussion and consensus among the expert panel. The quality assessment and the risk of bias are verified by Joanna Briggs Institute checklist (JBI) and The Newcastle-Ottawa Scale (NOS), and Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) assessment tool. RESULTS: A total of 452 records were identified in the based on our PICOs strategy and after screening, 19 articles were included in the descriptive analysis of the review. Totaling 473 implants placed in irradiated and non-irradiated bone, and 31.6% of the patients were over 60 years of age. 57.9%) performed implant placement in a period of 12 months or more after the ending of radiotherapy. Only 5 studies had a follow-up period longer than 5 years after implant placement, of which three were used for the meta-analysis. In the meta-analysis of 5-year survival rate, analysis of implants in irradiated bone was assessed; a random effect model was used and a weighted proportion (PP) of 93.13% (95% CI: 87.20-99.06; p < 0.001), and in the 5-year survival rate, analysis of implants in non-irradiated bone was analysed; a fixed effect model was used and a weighted proportion (PP) of 98.52% survival (95% CI: 97.56-99.48, p < 0.001). CONCLUSIONS: Survival rates of implants placed in irradiated bone are clinically satisfactory after a follow-up of 5 years, with a fewer percentage than in implants placed in non-irradiated bone after metanalyses performed.

Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters.

OBJECTIVE: This study presents the walking abilities of participants fitted with transfemoral bone-anchored prostheses using a total of 14 gait parameters. DESIGN: Two-centre retrospective cross-sectional comparative study. SETTING: Research facilities equipped with tridimensional motion capture systems. PARTICIPANTS: Two control arms included eight able-bodied participants arm (54 ± 9 years, 1.75 ± 0.07 m, 76 ± 7 kg) and nine participants fitted with transfemoral socket-suspended prostheses arm (59 ± 9 years, 1.73 ± 0.07 m, 80 ± 16 kg). The intervention arm included nine participants fitted with transfemoral bone-anchored prostheses arm (51 ± 13 years, 1.78 ± 0.09 m, 87.3 ± 16.1 kg). INTERVENTION: Fitting of transfemoral bone-anchored prostheses. MAIN MEASURES: Comparisons were performed for two spatio-temporal, three spatial and nine temporal gait parameters. RESULTS: The cadence and speed of walking were 107 ± 6 steps/min and 1.23 ± 0.19 m/s for the able-bodied participants arm, 88 ± 7 steps/min and 0.87 ± 0.17 m/s for the socket-suspended prosthesis arm, and 96 ± 6 steps/min and 1.03 ± 0.17 m/s for bone-anchored prosthesis arm, respectively. Able-bodied participants and bone-anchored prosthesis arms were comparable in age, height, and body mass index as well as cadence and speed of walking, but the able-bodied participant arm showed a swing phase 31% shorter. Bone-anchored and socket-suspended prostheses arms were comparable for age, height, mass, and body mass index as well as cadence and speed of walking, but the bone-anchored prosthesis arm showed a step width and duration of double support in seconds 65% and 41% shorter, respectively. CONCLUSIONS: Bone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of individuals using transfemoral bionics bone-anchored prostheses.

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BACKGROUND: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? METHODS: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. RESULTS: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. CONCLUSION: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. LEVEL OF EVIDENCE: Level III, therapeutic study.

New Osia® OSI200 active transcutaneous bone-anchored hearing device: how I do it.

INTRODUCTION: The new Osia® OSI200 implant incorporates a receiver coil and Piezo Power™ Transducer into one monolithic unit. Appropriate planning and surgical approach is needed for suitable positioning of the device. METHOD: To optimise the surgical field and provide tension-free wound closure our team have adopted a versatile 'Sheffield-S' post-auricular incision which remains hidden within the hairline. CONCLUSION: This incision provides adequate exposure for device placement and bone polishing/recessing. The soft tissue approach has resulted in improved operative efficacy particularly in those patients with irregular cortical bone or where pre-existing osseointegrated implants need to be removed or avoided.

Activities of daily living in lower limb amputees with a bone-anchored prosthesis: a retrospective case series with 24 months' follow-up.

BACKGROUND AND PURPOSE: Little is known about the activities of daily living (ADL) of patients with a bone-anchored prosthesis (BAP). We aimed to objectively measure ADL without and with BAP during standard care of follow-up. Our secondary aim was to measure mobility and walking ability. PATIENTS AND METHODS: Patients aged 18-99 years who underwent surgery for transfemoral or transtibial BAP between September 11, 2017, and February 11, 2021, were eligible for inclusion in this retrospective case series of patients with socket prosthesis. ADL was measured with a continuous recording activity monitor (hours [h]) before surgery, and at 6, 12, and 24 months with BAP. Mobility and walking ability were assessed by the Timed Up and Go test (TUG) (seconds [s]) and 6 Minute Walk Test (6MWT) (meters [m]), respectively. RESULTS: 48 of the 57 eligible patients provided informed consent and were included. Their age was 59 (1st quartile to 3rd quartile 51-63) years. Total daily activity before BAP was 1.6 h (0.82-2.1) and increased to 2.1 h (1.4-2.5) at 6, 2.0 h (1.5-2.7) at 12, and 2.7 h (2.0-3.3) at 24 months with BAP. Daily walking increased from 1.3 h (0.79-1.9) before BAP to 1.8 h (1.6-2.3) at 6, to 1.7 h (1.2-2.4) at 12, and 2.0 h (1.6-2.6) at 24 months. Median TUG decreased from 12 s (9.1-14) before BAP to 8.9 s (7.7-10) at 24 months. Mean 6MWT increased from 272 m (SD 92) before BAP to 348 m (SD 68) at 24 months. CONCLUSION: Objective measurements on ADL positively changed in patients with BAP. This effect was also seen in mobility and walking ability at 24 months.

A systematic review on removal of osseointegrated implants: un update.

BACKGROUND: Today dental implants represent an effective therapy in case of partial or total edentulism, with an excellent success rate. Despite the results obtained, there may be biological or mechanical complications during the therapy, which lead to the loss of the implant. This systematic review aims to evaluate the current state of the art in the literature on techniques used for the removal of dental implants. Various aspects will be analyzed, such as the success of the technique, any complications, and the advantages and disadvantages of their use. METHODS: Two reviewers conducted a literature analysis (PubMed, Embase, Web of Science) of the last 20 years (2003-2023). The main criterion analyzed was the success of the technique, while secondary outcomes such as complications and risks of the technique were also analyzed. 258 articles were identified in the various search databases. 42 eligible articles were subsequently identified after an article screening. Only 18 full texts were subsequently included in the review. RESULTS: A total of 18 articles were selected and 1142 implants and 595 patients were included. The main techniques used were the Counter-Torque Ratchet Technique (CTRT), Piezoelectric bone surgery (PBS), trephine drills, carbide burs, Erbium, Chromium, Yttrium, Scandium, Gallium, Garnett (Er:Cr:YSGG) laser and carbon dioxide (CO2) laser. Combined uses of techniques have been identified such as: PBS and trephine burs or carbide burs, trephine burs with the use of a 3d-printed guide, CTRT and trephine burs. The technique with the highest success rate, less morbidity for the patient, and less removal of bone appears to be the CTRT. CONCLUSIONS: The use of conservative techniques, especially CTRT, in bone removal is useful to allow for immediate implant placement in the removal area. However, further studies with a high sample size are needed to be performed on all techniques, particularly new randomized controlled trials (RCTs) that allow for the analysis of the success of alternative techniques such as Laser and Piezosurgery, which appear to be very promising.

Uprighting a mesially tilted molar using customized titanium healing abutment of an adjacent osseointegrated implant.

This case report evaluates the use of a customized healing abutment of a dental implant to upright a mesially tilted molar using elastic separating rings. The external surface of the healing abutment was roughened by air particle abrasion, and a flowable composite was applied as a collar around it. The size of the resin collar was increased several times during the molar uprighting treatment by replacing the elastic ring. The uprighting procedure was evaluated after 2 months using radiographic and clinical evaluations. After treatment, the mesiodistal space above the implant was increased from 6 mm to 9 mm as follows: 2 mm by uprighting the second molar and 1 mm by mesial shifting the second premolar, and then a screw-retained zirconia crown was placed to restore the implant. The healing abutment of the implant can be modified by adding a resin collar and used as orthodontic anchorage for uprighting the adjacent tilted molar to facilitate the prosthetic procedure. Neither special instruments nor an orthodontic background are required for this minor tooth movement.

Patient-Specific Guides for Accurate and Precise Positioning of Osseointegrated Implants in Transfemoral Amputations: A Proof-of-Concept In Vitro Study.

Background and Objectives: The treatment of transfemoral amputees using osseointegrated implants for prosthetic anchorage requires accurate implant positioning when using threaded bone-anchoring implants due to the curvature of the femur and the risk of cortical penetration in misaligned implants. This study investigated the accuracy and precision in implant positioning using additively manufactured case-specific positioning guides. Materials and Methods: The geometry and density distribution of twenty anatomic specimens of human femora were assessed in quantitative computed tomography (QCT) scanning. The imaging series were used to create digital 3D specimen models, preoperatively plan the optimal implant position and manufacture specimen-specific positioning guides. Following the surgical bone preparation and insertion of the fixture (threaded bone-anchoring element) (OPRA; Integrum AB, Mölndal, Sweden), a second QCT imaging series and 3D model design were conducted to assess the operatively achieved implant position. The 3D models were registered and the deviations of the intraoperatively achieved implant position from the preoperatively planned implant position were analyzed as follows. The achieved, compared to the planned implant position, was presented as resulting mean hip abduction or adduction (A/A) and extension or flexion (E/F) and mean implant axis offset in medial or lateral (M/L) and anterior or posterior (A/P) direction measured at the most distal implant axis point. Results: The achieved implant position deviated from the preoperative plan by 0.33 ± 0.33° (A/A) and 0.68 ± 0.66° (E/F) and 0.62 ± 0.55 mm (M/L) and 0.68 ± 0.56 mm (A/P), respectively. Conclusions: Using case-specific guides, it was feasible to achieve not only accurate but also precise positioning of the implants compared to the preoperative plan. Thus, their design and application in the clinical routine should be considered, especially in absence of viable alternatives.

A New Active Osseointegrated Implant System in Patients with Single-Sided Deafness.

OBJECTIVE: The Cochlear™ Osia® System (Osia) is an active transcutaneous bone conduction implant system intended for patients with conductive and mixed hearing loss but can also be used in cases of single-sided deafness (SSD) for the contralateral routing of signal (CROS). The Osia implant is placed subcutaneously under the intact skin behind the ear with the piezoelectric actuator connected to an osseointegrated BI300 implant - a titanium screw used for a 2-stage Baha surgery - on the mastoid. The external processor is magnetically attached to the subcutaneous implant receiver coil. As the Osia has recently been CE certified and is new on the market, with limited patient outcome data for SSD available, the objective of this study was the evaluation of surgical procedure, audiological results, and patient satisfaction for the Osia in SSD patients. STUDY DESIGN: In a prospective, monocentric clinical observation study, 6 patients (18 years of age or older) with SSD and bone conduction thresholds pure tone average 0.5, 1, 2, and 4 kHz ≤25 dB HL on the contralateral side were implanted with an Osia. Analysis of clinical outcome data with respect to surgical technique, adverse events, audiological measurement, and subjective benefit for SSD patients was conducted. Audiological measurements performed included hearing thresholds, sound field thresholds, word recognition scores (WRS; in %) in quiet, and speech recognition thresholds in noise (in dB SNR). All tests were performed unaided and aided with the Osia. The subjective benefit with the Osia was determined by using 2 questionnaires; the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSSD). RESULTS: Preliminary results indicate a straightforward surgical procedure with a low rate of complications and an improvement in speech perception in quiet, listening performance in everyday situations and patient satisfaction. However, in one of 6 subjects, a revision surgery had to be performed. CONCLUSION: Provided that SSD patients are open for CROS hearing, they can benefit from the Osia by reduced head shadow effects and better speech recognition. Special caution should be given to the skin at the site of implantation to avoid complications.

The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study.

OBJECTIVE: Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DESIGN: Single-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SETTING: Veterans Health Administration Hospital. PARTICIPANTS: Ten male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). INTERVENTIONS: All participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. OUTCOME MEASURES: Adverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. RESULTS: Ten male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. CONCLUSIONS: Improvements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.

What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?

BACKGROUND: Septic loosening and stem breakage due to metal fatigue is a rare but well-known cause of orthopaedic implant failure. This may also affect the components of the osseointegrated implant system for individuals with transfemoral amputation who subsequently undergo revision. Identifying risk factors is important to minimize the frequency of revision surgery after implant breakage. QUESTIONS/PURPOSES: (1) What proportion of patients who received an osseointegrated implant after transfemoral amputation underwent revision surgery, and what were the causes of those revisions? (2) What factors were associated with revision surgery when stratified by the location of the mechanical failure and (septic) loosening (intramedullary stem versus dual cone adapter)? METHODS: Between May 2009 and July 2015, we treated 72 patients with an osseointegrated implant. Inclusion criteria were a minimum follow-up of 5-years and a standard press-fit cobalt-chromium-molybdenum (CoCrMb) transfemoral osseointegrated implant. Based on that, 83% (60 of 72) of patients were eligible; a further 3% (2 of 60) were excluded because of no received informed consent (n = 1) and loss to follow-up (n = 1). Eventually, we included 81% (58 of 72) of patients for analysis in this retrospective, comparative study. We compared patient characteristics (gender, age, and BMI), implant details (diameter of the intramedullary stem, length of the dual cone, and implant survival time), and event characteristics (infectious complications and distal bone resorption). The data were retrieved from our electronic patient file and from our cloud-based database and analyzed by individuals not involved in patient care. Failures were categorized as: (1) mechanical failures, defined as breakage of the intramedullary stem or dual-cone adapter, or (2) (septic) loosening of the osseointegrated implant. RESULTS: Thirty-four percent (20 of 58) of patients had revision surgery. In 12% (7 of 58) of patients, the reason for revision was due to intramedullary stem failures (six breakages, one septic loosening), and in 22% (13 of 58) of patients it was due to dual-cone adaptor failure (10 weak-point breakages and four distal taper breakages; one patient broke both the weak-point and the dual-cone adapter). Smaller median stem diameter (failure: 15 mm [interquartile range 1.3], nonfailure: 17 mm [IQR 2.0], difference of medians 2 mm; p < 0.01) and higher median number of infectious events (failure: 6 [IQR 11], nonfailure: 1 [IQR 3.0], difference of medians -5; p < 0.01) were associated with revision intramedullary stem surgery. No risk factors could be identified for broken dual-cone adapters. CONCLUSION: Possible risk factors for system failure of this osteointegration implant include small stem diameter and high number of infectious events. We did not find factors associated with dual-cone adapter weak-point failure and distal taper failure, most likely because of the small sample size. When treating a person with a lower-limb amputation with a CoCrMb osseointegrated implant, we recommend avoiding a small stem diameter. Further research with longer follow-up is needed to study the success of revised patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

What Are the Long-term Surgical Outcomes of Compressive Endoprosthetic Osseointegration of the Femur with a Minimum 10-year Follow-up Period?

BACKGROUND: Endoprosthetic reconstruction after oncologic resection of bone tumors requires stable fixation between the prosthesis and residual host bone. Compressive osseointegration has been developed as an alternative to traditional stemmed implants to address the challenges and complications of achieving this fixation. Sufficient time has now passed from the advent of compressive implants to allow for an assessment of the intermediate-term and long-term results of this form of fixation. QUESTIONS/PURPOSES: At a minimum follow-up of 10 years after implantation of a compressive osseointegration device for oncologic reconstruction: (1) What is the risk of periprosthetic fracture, aseptic loosening, or implant breakage resulting in revision surgery for endoprosthesis removal? (2) What is the long-term cortical response at the host-endoprosthesis interface as visualized on plain radiographs? METHODS: A single-center, retrospective study was performed between 2002 and 2010, in which 110 patients with primary bone sarcoma of the proximal or distal femur were considered for oncologic resection and reconstruction. Patients were considered for a compressive osseointegration endoprosthesis if they were 50 years of age or younger, had not previously received femoral radiation, had no metabolic disease impairing bone healing, were not diagnosed with metastatic disease, and had life expectancy greater than six months. Of the 110 patients, 25 were treated with a compressive osseointegration implant of the proximal or distal femur, and 85 patients were treated with conventional stemmed implants or amputation because of older age, advanced disease, metabolic comorbidities, inability to tolerate a nonweightbearing postoperative period, or in the case of rotationplasty, patient preference. All patients who received this device during the period of study were considered eligible for inclusion in this review. The median (range) age was 18 years (7 to 50), and 13 of 25 patients were men. Five patients died of disease before the minimum follow-up duration of 10 years; two underwent amputation due to local recurrence and three died with the implant in situ, leaving 20 patients for complete analysis. Median follow-up was 144 months, and all 20 surviving patients had a minimum follow-up of 10 years (121 to 230 months). The primary endpoint was reoperation and implant removal for periprosthetic fracture, aseptic loosening, or mechanical breakage of any component of the compressive device in the endoprosthesis. In final analysis, death was considered a competing event to revision surgery, and cumulative incidence was reported after competing-event analysis. A secondary aim was radiographic evaluation of the host-implant interface to assess the long-term cortical response to compressive osseointegration. RESULTS: Spindle fracture or loosening was noted in three patients, and the remaining 17 patients maintained the compression device until the final follow-up. The risk of reoperation for aseptic loosening, periprosthetic fracture, or mechanical breakage of the implant using a competing risks estimator was 12% at 10 years (95% CI 0% to 26%). These complications occurred within 29 months of the index surgery; no patients had implant loosening or mechanical breakdown after this initial period. On radiographic assessment, 14 patients demonstrated cortical hypertrophy of the bone-implant interface, six patients had maintenance of the native cortical contour, and no patients had cortical atrophy or narrowing at the implant interface.Conclusion Long-term follow-up in patients with compressive osseointegrative endoprosthetic devices demonstrated no late revisions because of periprosthetic fracture, aseptic loosening, or implant breakage in this cohort with a minimum 10-year follow-up. There was no evidence of late-onset cortical atrophy or stress shielding at the host-implant interface. This study supports the long-term stability of the interface between host bone and the endoprosthesis in compressive osseointegration devices. LEVEL OF EVIDENCE: Level IV, therapeutic study.

The influence of antineoplastic agents on the peri-implant bone around osseointegrated titanium implants: an in vivo histomorphometric and immunohistochemical study.

BACKGROUND AND OBJECTIVE: The interaction between antineoplastic drugs used for treating cancer and non-affected tissues remains poorly assessed and may be critical for maintaining the quality of life for patients during and after treatment. This pre-clinical study evaluated the effects of cisplatin (CIS) and 5-fluorouracil (5-FU) on the peri-implant repair process around osseointegrated titanium implants installed in the tibiae of rats. MATERIAL AND METHODS: Were used 90 male rats, randomly divided into three groups (n = 30): physiological saline solution (PSS), CIS, and 5-FU. Titanium implants (4.0 × 2.2 mm) were inserted in both tibiae of all animals at day 0. The animals received either PSS, CIS, or 5-FU at 35 and 37 days. Euthanasia was performed at 50, 65, and 95 days after surgery. Histometric (bone/implant contact [BIC]) and bone area fraction occupancy (% BAFO), histological, and immunohistochemical (for bone morphogenetic protein 2/4 [BMP2/4], Runt-related transcription factor 2 [RUNX2], osteocalcin [OCN], and tartrate-resistant acid phosphatase [TRAP]) analyses were performed. Data were statistically analyzed. RESULTS: Groups CIS and 5-FU presented lower BIC and lower BAFO as compared with PSS in all time points. The imbalance in bone turnover was observed by the lower number of BMP2/4-, RUNX2-, and OCN-positive cells/mm2 and the higher number of TRAP-positive cells/mm in groups CIS and 5-FU as compared with PSS in all time points. Persistent and exacerbated inflammation was observed in groups CIS and 5-FU. CONCLUSIONS: Both antineoplastic agents interfered negatively in the bone turnover around osseointegrated titanium implants. CLINICAL RELEVANCE: Closer and more careful follow-up of patients with osseointegrated implants that will undergo chemotherapy with either CIS or 5-FU shall be performed.

Considerations and techniques for removal of osseointegrated implants.

Implant-supported restorations have become a successful, predictable, and mostly a first-choice strategy for replacement of missing teeth. However, complications such as implant fracture, malpositioned or poorly angled implants, and peri-implantitis persist in implant dentistry. Management of these complications may necessitate removal of an osseointegrated implant. Traditionally, implant removal has been a surgically invasive procedure; however, minimally invasive explantation techniques have evolved substantially over the last few years. This digital presentation describes various scenarios where osseointegrated implants require explantation, decision-making considerations, and techniques for removal of osseointegrated implants.

The biomechanical profile of an osseo-integrated rectangular block implant: A pilot in vivo experimental study.

OBJECTIVE: A novel implant design, the rectangular block implant (RBI), was investigated as a possible solution to the restoration of the posterior resorbed ridge. AIM: To maximally load test the osseo-integrated RBI in shear and tensile loads and relate these findings to known human masticatory loads as biomechanical proof of the study concept. MATERIALS AND METHODS: Twelve RBIs were design-manufactured and placed into posterior mandibular saddles in 3 mature greyhound dogs.-2 per left and right. After 12 weeks of healing, osseo-integration was confirmed using resonance frequency analysis (RFA) and wrench torque tests. Three bone blocks each with two RBIs were dissected and mounted in acrylic. Micro-computerized tomography (µ-CT) was performed to assess bone to implant contact (BIC), and load analysis was performed using a Universal Test System. Three force applications were conducted until failure: pull-out (tensile), buccal push from the lingual (shear) and distal push from the mesial (shear). The osteotomy sites were examined using light magnification and scanning electron microscopy (SEM). RESULTS: Pull-out, buccal and distal force failures occurred at differing levels. Post-detachment sites showed complex patterns of bone failure, including trabecular and cortical fracture, as well as shearing at varying distances from the BIC. Interfacial shear strength was calculated at 14.4 MPa. CONCLUSION: The osseo-integrated RBIs were able to withstand simulations of the demanding axially, bucco-lingually and mesio-distally oriented biomechanical challenges of the posterior saddle, under conditions of reduced bone volume. These values exceeded equivalent force components of maximal masticatory loads in humans.

Osseointegrated implant survival, success and prosthodontic outcomes in composite free flaps: A 10-year retrospective cohort study.

OBJECTIVES: To evaluate implant survival, success and prosthodontic outcomes in a variety of composite free flaps. MATERIAL AND METHODS: A retrospective analysis of patient records was used for data collection of implants placed into flaps. Free flap donor sites included fibula, iliac crest, scapula, medial femoral condyle and radial forearm. Kaplan-Meier survival curves were used to estimate survival. Cox regression was used to assess variables affecting survival, and binary logistic regression was utilised to determine effect of variables on prosthodontic outcomes. RESULTS: There were 150 implants placed into 45 fibula, 98 implants into 29 iliac crest, 62 implants into 22 scapula, 6 implants into 3 medial femoral condyle and 2 implants in radial forearm composite free flaps. There was no difference in survival or success between or within the various flaps. Active smoking, increasing age, male gender and radiotherapy were associated with implant failure. Of patients completing prosthodontic rehabilitation, 93% were successful. There was no difference in likelihood of failure between different flap types. Fixed implant-supported dentures were associated with poor oral hygiene compared with removable designs (OR2.9, 95%CI 1.1-7.8, p = .03). CONCLUSIONS: There is adequate survival and success of implants in common flaps. Caution is required when planning implants in patients exposed to radiotherapy and smokers. Ability to maintain adequate oral hygiene is an important prosthetic design consideration.

Compliant Compression Reconstruction of the Proximal Femur Is Durable Despite Minimal Bone Formation in the Compression Segment.

BACKGROUND: Compliant compression fixation was developed to promote permanent bone-prosthesis osteointegration while preserving bone stock in patients needing endoprosthetic reconstructions. This has demonstrated durability in the distal femur, with reliable cortical hypertrophy adjacent to the implant. However, the extent of bone formation and prosthetic survivorship of proximal femoral replacements with compliant compression fixation has not been established. QUESTIONS/PURPOSES: (1) How much bone formation occurs across the compression segment in patients treated with a proximal femoral replacement implant using compliant compression fixation? (2) What were the Musculoskeletal Tumor Society (MSTS) scores at minimum 24-month follow-up of patients who received this reconstruction? (3) What is the implant survivorship free from implant removal or revision for any reason at final follow-up? METHODS: From 2006 to 2018, we performed 213 proximal femoral replacements in patients with oncologic conditions of the proximal femur where the trochanters could not be preserved. Of these, 6% (12 of 213) were performed with an implant that used compliant compression fixation. We used this device in primary oncologic reconstructions in patients younger than 65 years of age without metastases who had nonirradiated bone with the requisite ≥ 2.5 mm of cortical thickness in the hope that it would provide more durable fixation and bone stock preservation than conventional reconstructions. All patients were followed for longer than 2 years except one who died in that interval. Median (range) follow-up was 6 years (2 to 10 years). Seven patients received diagnosis-specific chemotherapy in a consistent manner based on Children's Oncology Group chemotherapy protocols. Using the NIH-developed ImageJ open-access software, we measured the area of bone under compression on 3-, 6-, 9-, 12-, 18-, and 24-month radiographs and the length of the traction bar potential-compression distance, reconciling independent measures from two investigators using the identical method as published for the distal femur with compression fixation. The duration of prosthesis retention was evaluated using a competing risk analysis for the 11 surviving patients. RESULTS: Bone hypertrophy in the compression segment was scant. At the final analysis, cortical bone formation was a median (range) of 4 (-7 to 14) above baseline. The median (range) MSTS score was 27 (19 to 30). One implant failed after trauma, and the patient underwent revision of the implant. CONCLUSION: Despite scant bone formation across the compression segment and drastically less formation than reported for distal femoral replacements, compliant compression fixation of the proximal femur demonstrated good survivorship in patients 65 years or younger with localized sarcoma and nonirradiated, adequate bone stock in this small, retrospective series. Patients achieved good functional outcomes at final follow-up. The potential benefit of this reconstruction method should be weighed against the initial period of limited weightbearing and the life expectancy of the patient. LEVEL OF EVIDENCE: Level IV, cohort study.