THANCT06831045
Bikini vs Longitudinal Incision in Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)
A study testing Bikini Incision and Longitudinal Incision in people with THA, run by University of Miami at 1 site in United States.
Trial summary
The study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- THA
- What is being tested?
- Bikini Incision and Longitudinal Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with body mass index greater than or equal to 30
- Patients undergoing primary unilateral DAA THA
- Patients undergoing primary THA
Who cannot join
- Patients with body mass index less than 30
- Patients with a history of prior open surgery on the affected hip
- Patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (MAC)
- Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
- The following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Jonathan M Stern, MD, 305-243-1281, jms188@miami.edu
Natalia Cruz-Ossa, MD, 305-241-1281, nxc971@miami.edu
About this study
Official title: A Clinical Comparison in Wound Healing of Bikini Versus Longitudinal Incision in Direct Anterior Approach Total Hip Arthroplasty in the Obese Patient Population: A Randomized Control Trial
The study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique.
- Conditions
- THA
- Being tested
- Bikini Incision, Longitudinal Incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bikini IncisionProcedure or surgery
Participants will receive the bikini incision in person during THA. A one-time incision will be made along the groin line before standard of care THA surgery. The surgery takes approximately two hours.
Longitudinal IncisionProcedure or surgery
Participants will receive the longitudinal incision in person during THA. A one-time linear incision will be made along the thigh before standard-of-care THA surgery. The surgery takes approximately two hours.
| Study group | Role | What they receive |
|---|---|---|
| Bikini Incision Group | Experimental | Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days. Receives: Procedure: Bikini Incision |
| Longitudinal Incision Group | Experimental | Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days. Receives: Procedure: Longitudinal Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing measured in number of days
Will be measured in number of days the incision will take to heal.
Measured: Up to 14 days
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
Score ranges from 0 to 10. Higher scores indicate less satisfaction
Measured: Up to to 6 months
Scar cosmesis as measured by Observer Scar Assessment Scale
Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis
Measured: Up to 6 months
Secondary outcomes (5)
Number of participants who report lateral femoral cutaneous nerve-related symptoms
Number of participants who report lateral femoral cutaneous nerve-related symptoms
Measured: Up to 6 months
Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes
Scores range from 0 to 28. Higher scores indicate worse patient reported outcomes
Measured: Up to 6 months
Number of intraoperative fractures
Number of intraoperative fractures
Measured: Up to 3 hours
Length of surgery measured in minutes
Length of surgery measured in minutes
Measured: Up to 3 hours
Number of postoperative complications
Number of postoperative complications
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THAStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831045
- Sponsor's protocol ID
- 20230334
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison in Wound Healing of Bikini Versus Longitudinal Incision in Direct Anterior Approach Total Hip Arthroplasty in the Obese Patient Population: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06831045
- Acronym / sponsor ID
- 20230334
- Conditions
- THA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 17 Feb 2025 (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.
The study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bikini Incision Group | Experimental | Procedure: Bikini IncisionParticipants in this group will receive the bikini incision during THA. Total participation is up to 90 days. |
| Longitudinal Incision Group | Experimental | Procedure: Longitudinal IncisionParticipants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with body mass index greater than or equal to 30
- Patients undergoing primary unilateral DAA THA
- Patients undergoing primary THA
Key exclusion criteria (5 listed)
- Patients with body mass index less than 30
- Patients with a history of prior open surgery on the affected hip
- Patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (MAC)
- Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
- The following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
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 |
|---|---|---|
| Bikini IncisionParticipants will receive the bikini incision in person during THA. A one-time incision will be made along the groin line before standard of care THA surgery. The surgery takes approximately two hours. | Procedure or surgery | Bikini Incision Group |
| Longitudinal IncisionParticipants will receive the longitudinal incision in person during THA. A one-time linear incision will be made along the thigh before standard-of-care THA surgery. The surgery takes approximately two hours. | Procedure or surgery | Longitudinal Incision Group |
Primary outcome
Wound Healing measured in number of days
Time frame: Up to 14 days
Will be measured in number of days the incision will take to heal.
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
Time frame: Up to to 6 months
Score ranges from 0 to 10. Higher scores indicate less satisfaction
Scar cosmesis as measured by Observer Scar Assessment Scale
Time frame: Up to 6 months
Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis
5 secondary outcomes
Number of participants who report lateral femoral cutaneous nerve-related symptoms
Time frame: Up to 6 months
Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes
Time frame: Up to 6 months
Number of intraoperative fractures
Time frame: Up to 3 hours
Length of surgery measured in minutes
Time frame: Up to 3 hours
Number of postoperative complications
Time frame: Up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Victor H Hernandez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bikini Incision and Longitudinal Incision in people with THA, run by University of Miami 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor H Hernandez, MD (305-689-5195, vhh1@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing measured in number of days (time frame: Up to 14 days). The study lists 3 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 18 Mar 2026.