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

• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-26
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-27
• Study Start: 2025-10-01
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months	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.
Mean Dorsal Contour Irregularity Score on Blinded Photographic Assessment at 12 Months	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.
Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7	Post-op Day 1 and Day 7.	3 Clinicians-rated 4-point edema scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Mean Periorbital Ecchymosis Score on 4-Point Clinician Scale at Day 1 and Day 7	Post-op Day 1 and Day 7.	3 Clinician-rated 4-point ecchymosis scale (0-3).
Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months	12 months post-operation	Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors.
Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months	12 months post-operation	Symmetry rated by 3 blinded assessors on 3-point scale (symmetric / mildly asymmetric / asymmetric)
Number of Participants Requiring Unplanned Revision Surgery within 12 Months	Within 12 months post-operation	Any unplanned surgical revision related to the nasal dorsum

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months	12 months post-operation	Smooth vs Irregular, reported by 3 assessors
Mean Change in Nasal Obstruction Symptom Evaluation (NOSE) Score from Baseline to 12 Months	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.
Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7	Post-op Day 0 and Day 7	Pain measured on a 0-10 visual analogue scale (higher = more pain)
Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months	3 and 6 months post-operation	Presence of palpable or visible dorsal callus on clinical exam (Yes/No). 3 assessors.

Trial Locations

Locations (1)

Royal Hospital; 🇮🇶 Sulaymaniyah, KRI, Iraq