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
| Autor: | Stina Wigren, Manuela A. Joore, A.J.M. van der Rijt, M. van Hoof, Måns Eeg-Olofsson, Angelfish Collaborative, Joacim Stalfors, O. Deguine, J Ivarsson Blechert, S.J.H. Bom, Mark C. Flynn, J. Marco Algarra, D J M Mateijsen, Robert J. Stokroos |
|---|---|
| Přispěvatelé: | RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA AIOS Keel Neus Oorheelkunde (9), Health Services Research, RS: CAPHRI - R2 - Creating Value-Based Health Care |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Percutaneous TRANSCUTANEOUS IMPLANTS Hearing loss Population lcsh:Surgery law.invention RCT - randomized controlled trial surgery 03 medical and health sciences 0302 clinical medicine Randomized controlled trial LINEAR INCISION law Statistical significance INFECTION medicine AID education DERMATOME education.field_of_study COMPLICATIONS ASSESSMENT SCALE business.industry Soft tissue hydroxyapatite lcsh:RD1-811 soft tissue preservation Clinical Trial Surgery Clinical trial BAHA 030220 oncology & carcinogenesis Neuropathic pain randomized controlled trial SURVIVAL EXPERIENCE medicine.symptom business INTEGRATION 030217 neurology & neurosurgery RCT |
| Zdroj: | Frontiers in Surgery Frontiers in Surgery, Vol 7 (2020) Frontiers in Surgery, 7:5, 1-15. Frontiers Media S.A. |
| ISSN: | 2296-875X |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|