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NCT Number: NCT07142525

Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Rhinoplasty Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Hospital

Sulaymaniyah, KRI, 46001, Iraq

About this study

This prospective randomized controlled trial will evaluate the aesthetic and functional outcomes of hybrid osteoplasty using a surgical burr compared with traditional osteotomy and rasping in primary open rhinoplasty patients presenting with dorsal humps. The study population consists of adults without prior nasal surgery, trauma, or congenital deformities. Patients are randomized into two groups: Group A (hybrid osteoplasty) and Group B (traditional osteotomy plus rasping).

The primary objective is to assess differences in postoperative pain, edema, ecchymosis, dorsal smoothness, contour regularity, and patient satisfaction. Secondary outcomes include functional improvement measured by the Nasal Obstruction Symptom Evaluation (NOSE) score, aesthetic satisfaction assessed by the Rhinoplasty Outcome Evaluation (ROE), and the rate of revision surgery within 12 months.

Follow-up assessments are scheduled on postoperative Days 1, 2, and 7, and at 1, 3, 6, and 12 months. Standardized photographic documentation will support aesthetic evaluation, while clinical scoring systems will provide objective and subjective outcome data. The trial is powered to identify whether hybrid osteoplasty offers advantages in contour refinement and reduced soft tissue trauma compared with conventional osteotomy-based approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Drill-Assisted Dorsal Hump Reduction, Power-Assisted Osteoplasty, Burr 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.

Other names: Osteotome + Rasp Technique, Conventional Dorsal Hump Reduction

Primary outcomes

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

    Time frame: Baseline (preoperative) and 12 months post-operation.

    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.

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

    Time frame: 12 months post-operation.

    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.

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

    Time frame: Post-op Day 1 and Day 7.

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

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

    Time frame: Post-op Day 1 and Day 7.

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

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

    Time frame: 12 months post-operation

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

  6. Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months

    Time frame: 12 months post-operation

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

  7. Number of Participants Requiring Unplanned Revision Surgery within 12 Months

    Time frame: Within 12 months post-operation

    Any unplanned surgical revision related to the nasal dorsum

Secondary outcomes

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

    Time frame: 12 months post-operation

    Smooth vs Irregular, reported by 3 assessors

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

    Time frame: Baseline (preoperative) and 12 months post-operation.

    NOSE questionnaire scored 0-100 (higher = worse obstruction). Change is 12-month minus preoperative score; negative values indicate improvement.

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

    Time frame: Post-op Day 0 and Day 7

    Pain measured on a 0-10 visual analogue scale (higher = more pain)

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

    Time frame: 3 and 6 months post-operation

    Presence of palpable or visible dorsal callus on clinical exam (Yes/No). 3 assessors.

Sponsors and collaborators

Lead sponsor

University of Sulaimani

Other

Registry information

Official study title

Aesthetic and Functional Outcomes Following Hybrid Osteoplasty Versus Traditional Osteotomy in Rhinoplasty: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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