Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty (NCT07142525) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
Iraq200 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Rhinoplasty Outcome Evaluation (ROE) Score from Baseline to 12 Months
Timeframe: Baseline (preoperative) and 12 months post-operation.
2
Mean Dorsal Contour Irregularity Score on Blinded Photographic Assessment at 12 Months
Timeframe: 12 months post-operation.
3
Mean Periorbital Edema Score on 4-Point Clinician Scale at Day 1 and Day 7
Timeframe: Post-op Day 1 and Day 7.
4
Mean Periorbital Ecchymosis Score on 4-Point Clinician Scale at Day 1 and Day 7
Timeframe: Post-op Day 1 and Day 7.
5
Proportion of Participants with Residual Hump or Dorsal Depression on Blinded Photographic Assessment at 12 Months
Timeframe: 12 months post-operation
6
Proportion of Participants with Nasal Dorsum Width Symmetry at 12 Months
Timeframe: 12 months post-operation
7
Number of Participants Requiring Unplanned Revision Surgery within 12 Months