THA
Conditions
Brief 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.
Interventions
PROCEDUREBikini Incision
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.
PROCEDURELongitudinal Incision
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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with body mass index greater than or equal to 30 * Patients undergoing primary unilateral DAA THA * Patients undergoing primary THA
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing measured in number of days | 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 | 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 | Up to 6 months | Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who report lateral femoral cutaneous nerve-related symptoms | Up to 6 months | Number of participants who report lateral femoral cutaneous nerve-related symptoms |
| Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes | Up to 6 months | Scores range from 0 to 28. Higher scores indicate worse patient reported outcomes |
| Number of intraoperative fractures | Up to 3 hours | Number of intraoperative fractures |
| Length of surgery measured in minutes | Up to 3 hours | Length of surgery measured in minutes |
| Number of postoperative complications | Up to 90 days | Number of postoperative complications |
Countries
United States
Contacts
CONTACTVictor H Hernandez, MD
PRINCIPAL_INVESTIGATORVictor H Hernandez, MD
University of Miami
Outcome results
None listed