Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

N/ANot Yet RecruitingNCT07142525

University of Sulaimani200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Rhinoplasty Techniques

Interventions

Hybrid OsteoplastyPROCEDURE

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.

Traditional Osteotomy and RaspingPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Royal Hospital

Sulaymaniyah, KRI, Iraq

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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)

Time frame: 12 months post-operation

Number of Participants Requiring Unplanned Revision Surgery within 12 Months

Central Contacts

Goran L Omer, PhD

CONTACT

+9647721524848 goran.omer@univsul.edu.iq

Sahand S. Ali, MD