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Table 1 Schedule of enrolment, interventions, and assessments

From: Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

  1. Follow-up visits are planned post-surgery. Pain assessment: score for pain around the implant; radiating pain; headache associated with implant. Cosmetic result scores: score for natural skin position, baldness, scarring, skin color, indentation, overall cosmetic score. Light gray chart indicates measurements assessed at follow-up visits/extra consultations with a Holgers Index score ≥ 2
  2. RFA:ISQ Resonance Frequency Analysis: Implant Stability Quotient, HUI3 Health Utilities Index Mark 3, APHAB Abbreviated Profile of Hearing Aid Benefit, ICECAP-A ICEpop CAPability measure for Adults, N.A. not applicable, IS-pro a 16S-23S rDNA interspace (IS) region-based profiling method
  3. *Outcome measurements obtained at Maastricht University Medical Center only
  4. ˇOnly after explicit additional informed consent
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Trials

ISSN: 1745-6215