The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Change in iHOT Version 12
研究概览
简要总结
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 51 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 16-51 years of age.
- •Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
- •No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
- •No previous hip surgery
- •No other influential disabilities in lower limbs
- •No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
- •Base line activity level (Tegner 3 and above)
排除标准
- •Patients with concomitant disease that may affect joints
- •Patients with major ligamentous laxity
- •Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
- •Patients with extreme range of motion needs (such as ballet dancers)
- •Patients suffering from connective tissue disease
- •Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
- •Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
- •Patients who needed Ilio-Psoas release
- •Patients whose cartilage hip status was defined as advanced OA during surgery
- •Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
- •Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
- •Patients with preoperative hip stiffness
研究组 & 干预措施
Capsular Repair
Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not.
干预措施: Capsular Repair (Procedure)
No Capsular Repair
Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.
干预措施: No Capsular Repair (Procedure)
结局指标
主要结局
Change in iHOT Version 12
时间窗: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
次要结局
未报告次要终点