RhinoplastyNCT05566808
Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty
A study testing Autologous Costal Cartilage Graft and Costal Cartilage Allograft. in people with Rhinoplasty, run by Musculoskeletal Transplant Foundation at 1 site in United States.
Trial summary
This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- Autologous Costal Cartilage Graft and Costal Cartilage Allograft.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.
- Subject is willing to sign an informed consent.
- Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.
- Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.
Who cannot join
- Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.
- Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).
- History of radiation to the area(s) to be treated in the study.
- Subjects taking chronic steroids (injected or oral) or other immune modulators.
- Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.
- Subjects with skin conditions that could result in poor healing or widened scars.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures
This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).
- Conditions
- Rhinoplasty
- Being tested
- Autologous Costal Cartilage Graft, Costal Cartilage Allograft.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Costal Cartilage GraftOther
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
Costal Cartilage Allograft.Other
Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Costal Cartilage Graft | Other | Patients undergoing rhinoplasty will receive autologous rib graft. Receives: Other: Autologous Costal Cartilage Graft |
| Costal Cartilage Allograft | Other | Patients undergoing rhinoplasty will receive costal cartilage allograft. Receives: Other: Costal Cartilage Allograft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcome Assessment
Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.
Measured: Preoperative
Patient Outcome Assessment
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Measured: 3 months post-operative
Patient Outcome Assessment
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Measured: 6 months post-operative
Patient Outcome Assessment
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Measured: 12 months
Secondary outcomes (2)
Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.
Measured: 12 months
Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Mar 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Transplant Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566808
- Sponsor's protocol ID
- MTF Profile Study
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Evaluation the Long-term Outcomes Associated With the Use of MTF Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty Procedures
- ClinicalTrials.gov ID
- NCT05566808
- Acronym / sponsor ID
- MTF Profile Study
- Conditions
- Rhinoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Musculoskeletal Transplant FoundationUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, blinded, controlled trial, conducted in healthy adult subjects undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting of costal cartilage).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Costal Cartilage Graft | Other | Other: Autologous Costal Cartilage GraftPatients undergoing rhinoplasty will receive autologous rib graft. |
| Costal Cartilage Allograft | Other | Other: Costal Cartilage Allograft.Patients undergoing rhinoplasty will receive costal cartilage allograft. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is scheduled to undergo a reconstructive or cosmetic surgical procedure to alter the appearance of the nose that is anticipated to require a cartilage graft.
- Subject is willing to sign an informed consent.
- Subject is a non-smoker or has stopped smoking at least 6-weeks prior to inclusion in the study.
- Subjects must agree to forgo any treatment, medical or non-medical, to the area treated in this study, for the duration of the 1-year post-treatment evaluation period, unless there is prior approval from the investigator.
Key exclusion criteria (6 listed)
- Presence of significant endocrine, immunologic, dermatologic or psychiatric abnormalities that would render the subject an inappropriate candidate for the study.
- Presence of any malignancy not considered cured in the midface area specifically (no evidence of cancer recurrence in the previous five years).
- History of radiation to the area(s) to be treated in the study.
- Subjects taking chronic steroids (injected or oral) or other immune modulators.
- Subjects with a history of skin sensitivity (dermatitis) to either the suture materials or dressings to be utilized during the course of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Costal Cartilage GraftSubjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention. | Other | Autologous Costal Cartilage Graft |
| Costal Cartilage Allograft.Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention. | Other | Costal Cartilage Allograft |
Primary outcome
Patient Outcome Assessment
Time frame: Preoperative
Subjective assessment using the Face-Q checklists and scoring for preoperative assessment.
Patient Outcome Assessment
Time frame: 3 months post-operative
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Patient Outcome Assessment
Time frame: 6 months post-operative
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
Patient Outcome Assessment
Time frame: 12 months
Subjective assessment using the Face-Q checklists and scoring for post-operative assessments.
2 secondary outcomes
Cost analysis of utilizing the different grafts as far as graft cost, operative time, re-operation, etc.
Time frame: 12 months
Comparison of the overall complication rate between the MTF cartilage graft and autologous cartilage graft used during the procedures.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Costal Cartilage Graft and Costal Cartilage Allograft. in people with Rhinoplasty, run by Musculoskeletal Transplant Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Outcome Assessment (time frame: Preoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.