@article{a9f9767d7f544992be49f2f55769f09b,
title = "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",
abstract = "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.",
keywords = "BAHA, RCT, randomized controlled trial, hydroxyapatite, soft tissue preservation, surgery, TRANSCUTANEOUS IMPLANTS, ASSESSMENT SCALE, LINEAR INCISION, AID, COMPLICATIONS, INTEGRATION, EXPERIENCE, INFECTION, DERMATOME, SURVIVAL",
author = "{van Hoof}, M. and S. Wigren and Blechert, {J. Ivarsson} and Joore, {M. A.} and Mateijsen, {D. J. M.} and Bom, {S. J. H.} and J. Stalfors and Mans Eeg-Olofsson and O. Deguine and {van der Rijt}, {A. J. M.} and Flynn, {M. C.} and {Marco Algarra}, J. and Stokroos, {R. J.} and {Angelfish Collaborative}",
note = "Funding Information: The following people are acknowledged for significant contributions throughout the investigation by (co-)managing, language editing services or supporting the conduct of this clinical trial: A. Sandberg, A. Lewis and C. Hallberg (Cochlear Bone Anchored Solutions AB), A. Hellgren (Hellgren GCP Consulting AB), A. Oerlemans (Catharina Hospital), M. Bannink-von Hobe (Deventer Hospital), N.E.P.M. Swolfs (Amphia Hospital), Dr. M. Calmels and Dr. M. Marx (Purpan Hospital), M. Gual and M. del Carmen Peset (Clinical University Hospital, Valencia), drs. T.C.A. Calon (Maastricht University Medical Center, Maastricht), Prof. dr. B. Kremer (Maastricht University Medical Center, Maastricht). Our gratitude also goes out to audiological centers who supported subject recruitment and planning. We also highly appreciate the careful monitoring by S. Syren-Nordqvist (A+ Science, Stockholm, Sweden), and data management by Per Ekman (Statistiska konsultgruppen, G{\"o}teborg, Sweden). The following individuals served as collaborators and site investigators for the CBAS5439/NCT01796236 study. They participated in protocol development and review, local approval procedures, data collection and reviewed and revised the manuscript: M. van Hoof, S. Wigren, J. Ivarsson Blechert, M.C. Flynn, M{\aa}ns Eeg-Olofsson, J. Stalfors, M.A. Joore, M. Molin, J.R. Hof, J. van Tongeren, J.W. Brunings, L.J.C. Anteunis, M. I. Rincon Piedrahita, M.P. Martinez-Beneyto, D.J.M. Mateijsen, S.J.H. Bom, O. Deguine, A.J.M. van der Rijt, J. Marco Algarra, R.J. Stokroos. Funding Information: Conflict of Interest: This research was sponsored and funded by Cochlear Bone Anchored Solutions AB in full. SW, MF, and JB were paid employees of Cochlear Bone Anchored Solutions AB. MH declares a travel grant of Cochlear Bone Anchored Solutions AB. MM and HA are paid consultants to Cochlear Bone Anchored Solutions AB. Publisher Copyright: {\textcopyright} Copyright {\textcopyright} 2020 van Hoof, Wigren, Ivarsson Blechert, Joore, Mateijsen, Bom, Stalfors, Eeg-Olofsson, Deguine, van der Rijt, Flynn, Algarra, Stokroos and the Angelfish Collaborative.",
year = "2020",
month = mar,
day = "5",
doi = "10.3389/fsurg.2020.00005",
language = "English",
volume = "7",
pages = "1--15",
journal = "Frontiers in Surgery",
issn = "2296-875X",
publisher = "Frontiers Media S.A.",
}