Clinical Outcomes of Soft Tissue Preservation Surgery With Hydroxyapatite-Coated Abutments Compared to Traditional Percutaneous Bone Conduction Hearing Implant Surgery—A Pragmatic Multi-Center Randomized Controlled Trial

Hoof, Marc van; Wigren, Stina; Blechert, Johan Ivarsson; Joore, Manuela A.; Mateijsen, D.J.M.; Bom, S. J. H.; Stalfors, Joacim; Eeg-Olofsson, Måns; Déguine, Olivier; Rijt, A J M van der; Flynn, Mark; Algarra, Jaime Marco; Stokroos, Robert J.; Collaborative, Angelfish

doi:10.3389/fsurg.2020.00005

Cited by 6 publications

(16 citation statements)

References 46 publications

(52 reference statements)

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“…Because the pain scores related to the BCD (as judged by the patients) are generally low and not different between both techniques, it is not likely that this difference in the HUI- III could be attributed to the surgical technique. Finally, it is relevant to mention in this context that more invasive implantation techniques, such as the LITT-R and Dermatome technique, also have favorable pain scores (i.e., most patients experience no or only mild pain) ( 8 , 22 ).…”

Section: Discussionmentioning

confidence: 99%

“…Besides variations in implant and abutment design, for example, the hydroxyapatite layer of the BIA400 from Cochlear (Mölnlycke, Sweden) ( 8 , 9 ) and the smooth titanium surface of the Ponto Wide from Oticon Medical AB (Askim, Sweden) ( 10 , 11 ), there have been advances in surgical techniques. Initially, subcutaneous tissue was removed in an attempt to reduce friction skin movements around the abutment.…”

Section: Introductionmentioning

confidence: 99%

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Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

et al. 2021

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Objective: Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months.Methods: In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires.Results: Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%).Conclusion: The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02438618.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

et al. 2021

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“…A power calculation was performed; (23); in summary 100 evaluable patients were considered to be necessary to detect a significant cost saving. Consequences and effect sizes were calculated using the area under the curve (AUC) with linear interpolation to be able to use the three measurement points during the first year (baseline, 6 months, 1 and 3 years) for the APHAB and HUI3.…”

Section: Discussionmentioning

confidence: 99%

“…The current cost-consequence analysis (CCA) is part of a randomized controlled trial (RCT) which was performed in four European countries of which the clinical results are reported separately (23). The clinical report shows that the primary efficacy outcome difference after 1 year was not statistically significant (29 vs. 13%, p = 0.12) in the intention-to-treat (ITT) population.…”

Section: Study Rationalementioning

confidence: 99%

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A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

Hoof

Wigren²,

Blechert³

et al. 2020

Front. Neurol.

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Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control).Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL e86 (CI −50.33; 219.20), FR e134 (CI −3.63; 261.30), ES e178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE e-29 CI −160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to e17 (CI −191.80; 213.30) in the Netherlands, in Spain to e84.50 (CI −117.90; 289.50), and in France to van Hoof et al. CCA of Less Invasive Treatment e80 (CI −99.40; 248.50). The mean additional cost in Sweden increased to e-116 (CI −326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician.Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha ® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

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The bone anchored prostheses for amputees – Historical development, current status, and future aspects

Felländer‐Tsai

2021

Biomaterials

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Clinical Outcomes of Soft Tissue Preservation Surgery With Hydroxyapatite-Coated Abutments Compared to Traditional Percutaneous Bone Conduction Hearing Implant Surgery—A Pragmatic Multi-Center Randomized Controlled Trial

Cited by 6 publications

References 46 publications

Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

The bone anchored prostheses for amputees – Historical development, current status, and future aspects

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