Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty

University of Sulaimani

Status: Not yet enrolling

Conditions: Rhinoplasty Techniques

Treatments: Procedure: Hybrid Osteoplasty; Procedure: Traditional Osteotomy and Rasping

Study type: Interventional

Funder types: Other

Identifiers

NCT07142525

No. 159 (August 17th, 2025)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Hybrid Osteoplasty

Experimental group

Description:

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

Treatment:

Procedure: Hybrid Osteoplasty

Traditional Osteotomy and Rasping

Active Comparator group

Description:

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.

Treatment:

Procedure: Traditional Osteotomy and Rasping