Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bikini Incision Group | Experimental | Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days. |
|
| Longitudinal Incision Group | Experimental | Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bikini Incision | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing measured in number of days | Will be measured in number of days the incision will take to heal. | 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 | 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 | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who report lateral femoral cutaneous nerve-related symptoms | Number of participants who report lateral femoral cutaneous nerve-related symptoms | Up to 6 months |
| Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor H Hernandez, MD | Contact | 305-689-5195 | vhh1@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Longitudinal Incision | Procedure | 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. |
|
Scores range from 0 to 28. Higher scores indicate worse patient reported outcomes |
| Up to 6 months |
| Number of intraoperative fractures | Number of intraoperative fractures | Up to 3 hours |
| Length of surgery measured in minutes | Length of surgery measured in minutes | Up to 3 hours |
| Number of postoperative complications | Number of postoperative complications | Up to 90 days |