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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with body mass index greater than or equal to 30
- •Patients undergoing primary unilateral DAA THA
- •Patients undergoing primary THA
排除标准
- •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.
研究组 & 干预措施
Bikini Incision Group
Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days.
干预措施: Bikini Incision (Procedure)
Longitudinal Incision Group
Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days.
干预措施: Longitudinal Incision (Procedure)
结局指标
主要结局
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
时间窗: 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
时间窗: Up to 6 months
Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis
Wound Healing measured in number of days
时间窗: Up to 14 days
Will be measured in number of days the incision will take to heal.
次要结局
- 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(Up to 6 months)
- Number of intraoperative fractures(Up to 3 hours)
- Length of surgery measured in minutes(Up to 3 hours)
- Number of postoperative complications(Up to 90 days)
研究者
Victor Hugo Hernandez
Professor of Clinical Orthopedics
University of Miami