Dataset Information

Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique.

ABSTRACT: OBJECTIVES:To evaluate the three-year clinical and audiological outcomes of soft-tissue preservation compared to soft-tissue reduction in linear incision surgery for percutaneous implant for bone conduction (BC) devices. METHODS:Twenty-five patients (25 implants) were enrolled in a prospective cohort for implant surgery with linear incision and tissue preservation. The control group consisted of 25 patients (25 implants) from a previous randomized controlled trial in which a linear incision with soft-tissue reduction was applied. Follow-up visits were scheduled at 7 and 21 days (fitting of sound processor); 12 weeks; 6 months; and at 1, 2, and 3 years after implantation. Main outcome measures were skin sensibility, soft-tissue status, Implant Stability Quotient (ISQ), skin height, implant survival, revision surgery, scar assessment, and hearing thresholds (BC in-situ between 250 Hz and 8?kHz with BC device on testband and abutment, and BC thresholds at 250Hz-4?kHz with a B71 bone conductor). RESULTS:Tissue preservation resulted in superior sensibility (mean percentage correct responses 99.7% [SD 1.7] vs 92.0% [SD 9.2], p?=?0.0001). No spontaneous implant loss occurred in either group. The abutment was removed in two tests and in one control patient. Two control patients needed skin revision surgery. Although not statistically significant, more adverse soft-tissue reactions (Holgers ?2) were observed in the test-group (n?=?9 [36%] vs n?=?3 [12%], p?=?0.095). ISQ increased significantly more in the test group compared to the control group (7.64 [SD 4.05] vs 4.29 [SD 3.93]). Skin thickening, scar assessment, and hearing outcomes were comparable. CONCLUSION:Tissue preservation demonstrated superior skin sensibility compared to tissue reduction while other clinical outcomes were comparably excellent.

SUBMITTER: Kruyt IJ

PROVIDER: S-EPMC6380444 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique.

Kruyt Ivo J IJ Kok Herman H Bosman Arjan A Nelissen Rik Chrétien RC Mylanus Emmanuel Antonia Maria EAM Hol Myrthe Karianne Sofie MKS

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20190301 3

<h4>Objectives</h4>To evaluate the three-year clinical and audiological outcomes of soft-tissue preservation compared to soft-tissue reduction in linear incision surgery for percutaneous implant for bone conduction (BC) devices.<h4>Methods</h4>Twenty-five patients (25 implants) were enrolled in a prospective cohort for implant surgery with linear incision and tissue preservation. The control group consisted of 25 patients (25 implants) from a previous randomized controlled trial in which a linea ...[more]

PMID: 30742596

Similar Datasets

Project description:OBJECTIVE:To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS). DESIGN:Sponsor-initiated multicenter, open, randomized, controlled clinical trial. SETTING:Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands. PARTICIPANTS:Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS:Primary objective: compare the incidence of inflammation (Holgers Index ? 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements. RESULTS:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time. CONCLUSION:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

Project description:BackgroundOver the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.MethodsA multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.DiscussionThis is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.Trial registrationRegistered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.

Project description:Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.

Project description:BackgroundTransdermal osseointegrated prosthesis have relatively high infection rates leading to implant revision or failure. A principle cause for this complication is the absence of a durable impervious biomechanical seal at the interface of the hard structure (implant) and adjacent soft tissues. This study explores the possibility of recapitulating an analogous cellular musculoskeletal-connective tissue interface, which is present at naturally occurring integumentary tissues where a hard structure exits the skin, such as the nail bed, hoof, and tooth.MethodsPorcine mesenchymal stromal cells (pMSCs) were derived from nine different porcine integumentary and connective tissues: hoof-associated superficial flexor tendon, molar-associated periodontal ligament, Achilles tendon, adipose tissue and skin dermis from the hind limb and abdominal regions, bone marrow and muscle. For all nine pMSCs, the phenotype, multi-lineage differentiation potential and their adhesiveness to clinical grade titanium was characterized. Transcriptomic analysis of 11 common genes encoding cytoskeletal proteins VIM (Vimentin), cell-cell and cell-matrix adhesion genes (Vinculin, Integrin β1, Integrin β2, CD9, CD151), and for ECM genes (Collagen-1a1, Collagen-4a1, Fibronectin, Laminin-α5, Contactin-3) in early passaged cells was performed using qRT-PCR.ResultsAll tissue-derived pMSCs were characterized as mesenchymal origin by adherence to plastic, expression of cell surface markers including CD29, CD44, CD90, and CD105, and lack of hematopoietic (CD11b) and endothelial (CD31) markers. All pMSCs differentiated into osteoblasts, adipocytes and chondrocytes, albeit at varying degrees, under specific culture conditions. Among the eleven adhesion genes evaluated, the cytoskeletal intermediate filament vimentin was found highly expressed in pMSC isolated from all tissues, followed by genes for the extracellular matrix proteins Fibronectin and Collagen-1a1. Expression of Vimentin was the highest in Achilles tendon, while Fibronectin and Col1agen-1a1 were highest in molar and hoof-associated superficial flexor tendon bone marrow, respectively. Achilles tendon ranked the highest in both multilineage differentiation and adhesion assessments to titanium metal.ConclusionsThese findings support further preclinical research of these tissue specific-derived MSCs in vivo in a transdermal osseointegration implant model.

Dataset Information

Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique.

Publications

Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets