Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

Not Applicable

Not yet recruiting

• Conditions: Rhinoplasty Techniques

• Registration Number: NCT07142525
• Lead Sponsor: University of Sulaimani

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.

Detailed Description

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Study Start: 2025-09-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Primary open rhinoplasty planned, Dorsal hump with a bony or mixed component judged preoperatively to be amenable to either technique, No prior nasal surgery or significant nasal trauma affecting the 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 of the nose/skin, open lesions, or uncontrolled dermatologic conditions at the operative field, Bleeding diathesis, platelet disorder, INR elevation, or anticoagulant/antiplatelet therapy that cannot be safely paused, Uncontrolled systemic disease (e.g., poorly controlled hypertension, diabetes) or ASA ≥ IV, Pregnancy or breastfeeding, Chronic isotretinoin use within the past 6 months or long-term systemic corticosteroid use that may affect healing, Concurrent interventional study that could influence healing, edema, bruising, satisfaction, or revision rates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in ROE Score	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.
Aesthetic Dorsal Contour Regularity	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.
Periorbital Ecchymosis Score	Post-op Day 2 and Day 7.	3 Clinician-rated 4-point ecchymosis scale (0-3).
Periorbital Edema Score	Post-op Day 2 and Day 7.	3 Clinicians-rated 4-point edema scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).; Time Frame: Post-op Day 2 and Day 7.
Residual Hump or Dorsal Depression	12 months post-operation	Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors.
Width Symmetry of Nasal Dorsum	12 months post-operation	Symmetry rated by 3 blinded assessors on 3-point scale (symmetric / mildly asymmetric / asymmetric)
Revision Surgery	Within 12 months post-operation	Any unplanned surgical revision related to the nasal dorsum

Secondary Outcome Measures

Name	Time	Method
Dorsal Smoothness (Non-Blinded Binary)	12 months post-operation	Smooth vs Irregular, reported by 3 assessors
Early Pain (VAS)	Post-op Day 1 and Day 7	Pain measured on a 0-10 visual analogue scale (higher = more pain)
Callus Formation at Nasal Dorsum	3 and 6 months post-operation	Presence of palpable or visible dorsal callus on clinical exam (Yes/No). 3 assessors.
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score	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.

Trial Locations

Locations (1)

Royal Hospital; 🇮🇶 Sulaymaniyah, KRI, Iraq