Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
研究概览
简要总结
This study aims to address hip labral tears and compare arthroscopic labral repair versus debridement in non-athletic population aged 20 to 50 years old, including both sexes.
详细描述
Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.
Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: both sexes.
- •Age: 20 years - 50 years, non-athletes.
- •Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
排除标准
- •Previous hip surgery.
- •Hip joint dysplasia, defined by both center edge (CE) angles <25 degrees and Acetabular Index angle >10 degrees.
- •Osteoarthritis grade >2 according to Tönnis classification.
研究组 & 干预措施
Labral Repair
Labral tears will be repaired with suture anchors.
干预措施: Arthroscopic Labral Repair (Procedure)
Labral Debridement
Labral Debridement will be done
干预措施: Arthroscopic Labral Debridement (Procedure)
结局指标
主要结局
Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
时间窗: Baseline, 1 year
\<70 (poor result), 70-79 (fair result), 80-89 (good result) and \>90 (excellent result)
Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)
时间窗: Baseline, 1 year
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4). Scores for each subscale range from 0% (least function) to 100% (most function).The highest potential score is 68, a higher score represents a higher level of physical function for both the ADL and sports subscales
Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)
时间窗: Baseline, 1 year
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain, and higher scores indicating greater pain
次要结局
未报告次要终点
研究者
Karim Atef Salem
Principal Investigator
Ain Shams University