Aesthetic and Functional Outcomes Following Hybrid Osteoplasty Versus Traditional Osteotomy in Rhinoplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hybrid Osteoplasty
Participants undergo dorsal hump reduction using a surgical burr (drill) without traditional dorsal osteotomy. The technique allows controlled bone contouring under direct visualization.
干预措施: Hybrid Osteoplasty (Procedure)
Traditional Osteotomy and Rasping
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.
干预措施: Traditional Osteotomy and Rasping (Procedure)
结局指标
主要结局
Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months
时间窗: 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
时间窗: 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.
Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months
时间窗: 12 months post-operation
Blinded photographic assessment for remnant hump or depression (present/absent), by 3 assessors.
Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7
时间窗: 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
时间窗: Post-op Day 1 and Day 7.
3 Clinician-rated 4-point ecchymosis scale (0-3).
Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months
时间窗: 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
时间窗: Within 12 months post-operation
Any unplanned surgical revision related to the nasal dorsum
Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Within 12 months post-operation
Any unplanned surgical revision related to the nasal dorsum
次要结局
- Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months(12 months post-operation)
- Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7(Post-op Day 0 and Day 7)
- Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months(3 and 6 months post-operation)
- Proportion of Participants with Smooth Nasal Dorsum (Non-Blinded Binary Assessment) at 12 Months(12 months post-operation)
- Mean Change in Nasal Obstruction Symptom Evaluation (NOSE) Score from Baseline to 12 Months(Baseline (preoperative) and 12 months post-operation.)
- Mean Pain Score on 0-10 Visual Analogue Scale at Post-Op Day 0 and Day 7(Post-op Day 0 and Day 7)
- Proportion of Participants with Palpable or Visible Dorsal Callus on Clinical Exam at 3 and 6 Months(3 and 6 months post-operation)
研究者
Assoc. Prof. Dr. Goran Latif Omer
Associate Professor
University of Sulaimani