Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

NCT07142525 | Not Yet Recruiting DMC

• 1 other identifier: No. 159 (August 17th, 2025)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare two common techniques for reducing the nasal hump during rhinoplasty: the traditional method using osteotomes and rasps, and a newer technique called hybrid osteoplasty that uses a surgical drill. Both approaches aim to improve the appearance and function of the nose. The trial will measure pain, swelling, bruising, and the smoothness of the nasal bridge, as well as patient satisfaction and breathing outcomes. Participants will be followed for one year to assess both early healing and long-term results.

Conditions

Rhinoplasty Techniques

Keywords

Osteoplasty; Dorsal Hump; Rhinoplasty

Outcome Measures

Primary Outcomes (7)

• Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months

  ROE (Rhinoplasty Outcome Evaluation) questionnaire scored 0-100 (higher = greater satisfaction). Score calculated per instrument guidance from the 6 items, converted to 0-100. Change is 12-month minus preoperative score.

  Baseline (preoperative) and 12 months post-operation.

• Mean Dorsal Contour Irregularity Score on Blinded Photographic Assessment at 12 Months

  Standardized 7-view photographs rated by three blinded surgeons using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe irregularity). Primary analysis compares group means; inter-rater agreement assessed.

  12 months post-operation.

• Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7

  3 Clinicians-rated 4-point edema scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

  Post-op Day 1 and Day 7.

• Mean Periorbital Ecchymosis Score on 4-Point Clinician Scale at Day 1 and Day 7

  3 Clinician-rated 4-point ecchymosis scale (0-3).

  Post-op Day 1 and Day 7.

• Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months

  Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors.

  12 months post-operation

• Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months

  Symmetry rated by 3 blinded assessors on 3-point scale (symmetric / mildly asymmetric / asymmetric)

  12 months post-operation

• Number of Participants Requiring Unplanned Revision Surgery within 12 Months

  Any unplanned surgical revision related to the nasal dorsum

  Within 12 months post-operation

Secondary Outcomes (4)

• Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months

  12 months post-operation

• Mean Change in Nasal Obstruction Symptom Evaluation (NOSE) Score from Baseline to 12 Months

  Baseline (preoperative) and 12 months post-operation.

• Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7

  Post-op Day 0 and Day 7

• Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months

  3 and 6 months post-operation

Study Arms (2)

Hybrid Osteoplasty

EXPERIMENTAL

Participants undergo dorsal hump reduction using a surgical burr (drill) without traditional dorsal osteotomy. The technique allows controlled bone contouring under direct visualization.

Procedure: Hybrid Osteoplasty

Traditional Osteotomy and Rasping

ACTIVE COMPARATOR

Participants undergo dorsal hump reduction using the conventional method of osteotomy combined with rasping. This is the established standard approach for contouring the nasal dorsum.

Procedure: Traditional Osteotomy and Rasping

Interventions

Hybrid Osteoplasty PROCEDURE

Open rhinoplasty with dorsal hump reduction performed using a powered surgical burr under irrigation and direct visualization. Bone is contoured gradually to achieve a smooth dorsum while preserving the keystone area. No dorsal osteotomy is performed in this arm. Cartilaginous work and adjunctive steps (e.g., septoplasty or tip refinement) are performed as clinically indicated but are not part of the intervention being tested.

Also known as: Drill-Assisted Dorsal Hump Reduction, Power-Assisted Osteoplasty, Burr Osteoplasty

Hybrid Osteoplasty

Traditional Osteotomy and Rasping PROCEDURE

Open rhinoplasty using the conventional technique for dorsal hump reduction. The bony hump is resected with a straight osteotome, followed by manual rasping to refine the nasal dorsum, with preservation of the keystone area. Powered burrs are not used for primary dorsal contouring in this arm. Cartilaginous work and adjunctive procedures may be performed as clinically indicated but are not part of the tested intervention.

Also known as: Osteotome + Rasp Technique, Conventional Dorsal Hump Reduction

Traditional Osteotomy and Rasping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary open rhinoplasty planned.
• Dorsal hump with bony or mixed component suitable for either technique.
• No prior nasal surgery or significant nasal trauma affecting dorsum.
• ASA I-III and fit for general anesthesia.
• Willing to provide written informed consent, including standardized photography.
• Able and willing to attend all follow-up visits through 12 months.

You may not qualify if:

• Revision rhinoplasty or prior osteotomy/osseocartilaginous work.
• Active infection, open lesions, or uncontrolled dermatologic conditions at operative field.
• Bleeding diathesis, platelet disorder, INR elevation, or anticoagulant/antiplatelet therapy that cannot be paused.
• Uncontrolled systemic disease (e.g., hypertension, diabetes) or ASA ≥ IV.
• Pregnancy or breastfeeding.
• Chronic isotretinoin use within past 6 months or long-term systemic corticosteroid use.
• Concurrent interventional study that may affect healing or outcomes.

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

Royal Hospital

Sulaymaniyah, KRI, 46001, Iraq

Location

Related Publications (12)

• Azizli E, Bayar Muluk N, Dundar R, Cingi C. A new preservation technique for dehumping the dorsum. Eur Rev Med Pharmacol Sci. 2023 Mar;27(2 Suppl):57-62. doi: 10.26355/eurrev_202303_31703.

  PMID: 36971222 BACKGROUND

• Ferreira MG, Monteiro D, Reis C, Almeida e Sousa C. Spare Roof Technique: A Middle Third New Technique. Facial Plast Surg. 2016 Feb;32(1):111-6. doi: 10.1055/s-0035-1570503. Epub 2016 Feb 10.

  PMID: 26862972 BACKGROUND

• Aldosari BF, Alhajress RI, Bogari AO. Hump Rasping Using Powered Instruments: A Retrospective Review. Plast Reconstr Surg Glob Open. 2024 Sep 10;12(9):e6153. doi: 10.1097/GOX.0000000000006153. eCollection 2024 Sep.

  PMID: 39258281 BACKGROUND

• Lal GN, Ghosh P. Use of drill in rhinoplasty (a case report). Indian J Otolaryngol Head Neck Surg. 1999 Jan;51(1):90-2. doi: 10.1007/BF02996859.

  PMID: 23119498 BACKGROUND

• Goodman WS. The rotating burr in rhinoplasty. Arch Otolaryngol. 1981 Jul;107(7):436-8. doi: 10.1001/archotol.1981.00790430038010. No abstract available.

  PMID: 7247809 BACKGROUND

• Avashia YJ, Marshall AP, Allori AC, Rohrich RJ, Marcus JR. Decision-Making in Middle Vault Reconstruction following Dorsal Hump Reduction in Primary Rhinoplasty. Plast Reconstr Surg. 2020 Jun;145(6):1389-1401. doi: 10.1097/PRS.0000000000006850.

  PMID: 32195860 BACKGROUND

• Barrett DM, Casanueva F, Wang T. Understanding Approaches to the Dorsal Hump. Facial Plast Surg. 2017 Apr;33(2):125-132. doi: 10.1055/s-0037-1598033. Epub 2017 Apr 7.

  PMID: 28388791 BACKGROUND

• Fuller JC, Hilger PA. Modified Skoog Method for Hump Reduction. Facial Plast Surg Clin North Am. 2021 Feb;29(1):131-139. doi: 10.1016/j.fsc.2020.09.008.

  PMID: 33220838 BACKGROUND

• Sowder JC, Thomas AJ, Gonzalez CD, Limaye NS, Ward PD. Use of Spreader Flaps Without Dorsal Hump Reduction and the Effect on Nasal Function. JAMA Facial Plast Surg. 2017 Jul 1;19(4):287-292. doi: 10.1001/jamafacial.2016.2057.

  PMID: 28241228 BACKGROUND

• Azizzadeh B, Reilly M. Dorsal Hump Reduction and Osteotomies. Clin Plast Surg. 2016 Jan;43(1):47-58. doi: 10.1016/j.cps.2015.09.022. Epub 2015 Oct 23.

  PMID: 26616694 BACKGROUND

• Roostaeian J, Unger JG, Lee MR, Geissler P, Rohrich RJ. Reconstitution of the nasal dorsum following component dorsal reduction in primary rhinoplasty. Plast Reconstr Surg. 2014 Mar;133(3):509-518. doi: 10.1097/01.prs.0000438453.29980.36.

  PMID: 24263393 BACKGROUND

• Rohrich RJ, Muzaffar AR, Janis JE. Component dorsal hump reduction: the importance of maintaining dorsal aesthetic lines in rhinoplasty. Plast Reconstr Surg. 2004 Oct;114(5):1298-308; discussion 1309-12. doi: 10.1097/01.prs.0000135861.45986.cf.

  PMID: 15457053 BACKGROUND

Study Officials

• Goran L Omer, PhD

  University of Sulaimani

  STUDY CHAIR

Central Study Contacts

Goran L Omer, PhD

CONTACT

+9647721524848; goran.omer@univsul.edu.iq

Sahand S. Ali, MD

CONTACT

+9647729968844; sahand.soran@auis.edu.krd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD and supporting information will be available beginning after publication of the primary study results and will remain available for a minimum of 5 years thereafter.
• Access Criteria: De-identified IPD and supporting documents will be made available to qualified researchers affiliated with academic institutions or recognized research organizations. Requests must include a methodologically sound proposal and will be reviewed by the principal investigator. Approved requestors will be required to sign a data use agreement ensuring compliance with ethical and confidentiality standards. Data will be provided in de-identified format via secure transfer.

Locations

IR (1)