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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005174naa a2200661 4500
001oai:gup.ub.gu.se/295840
003SwePub
008240528s2020 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/2958402 URI
0247 a https://doi.org/10.3389/fsurg.2020.000052 DOI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a van Hoof, M.4 aut
2451 0a 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
264 c 2020-03-05
264 1b Frontiers Media SA,c 2020
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicin0 (SwePub)3022 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicine0 (SwePub)3022 hsv//eng
653 a BAHA
653 a RCT
653 a randomized controlled trial
653 a hydroxyapatite
653 a soft tissue
653 a preservation
653 a surgery
653 a transcutaneous implants
653 a assessment scale
653 a linear incision
653 a aid
653 a complications
653 a integration
653 a experience
653 a infection
653 a dermatome
653 a survival
653 a Surgery
7001 a Wigren, S.4 aut
7001 a Blechert, J. I.4 aut
7001 a Joore, M. A.4 aut
7001 a Mateijsen, D. J. M.4 aut
7001 a Bom, S. J. H.4 aut
7001 a Stalfors, Joacim,d 1966u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för öron-, näs- och halssjukdomar,Institute of Clinical Sciences, Department of Otorhinolaryngology4 aut0 (Swepub:gu)xstalj
7001 a Eeg-Olofsson, Måns,d 1967u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för öron-, näs- och halssjukdomar,Institute of Clinical Sciences, Department of Otorhinolaryngology4 aut0 (Swepub:gu)xeegma
7001 a Deguine, O.4 aut
7001 a van der Rijt, A. J. M.4 aut
7001 a Flynn, M. C.4 aut
7001 a Algarra, J. M.4 aut
7001 a Stokroos, R. J.4 aut
7001 a Angelfish, Collaborative4 aut
7102 a Göteborgs universitetb Institutionen för kliniska vetenskaper, Avdelningen för öron-, näs- och halssjukdomar4 org
7730 t Frontiers in Surgeryd : Frontiers Media SAg 7q 7x 2296-875X
8564 u https://www.frontiersin.org/articles/10.3389/fsurg.2020.00005/pdf
8564 8u https://gup.ub.gu.se/publication/295840
8564 8u https://doi.org/10.3389/fsurg.2020.00005

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