Weight Bearing as Tolerated (WBAT) Following Hip Arthroscopic Labral Repair and Femoroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- International Hip Outcome Tool 12 (iHot-12)
研究概览
简要总结
This study is being proposed to examine weight bearing precautions following hip arthroscopic labral repair, femoroplasty, and capsular closure. Standard post operative protocols limit weight bearing for 2-6 weeks depending on individual surgeons. Cadaveric studies demonstrate that minimal force during weight bearing is distributed through labrum. Therefore, progressing weight bearing earlier in these patients post operatively may help progress faster and improve outcomes. Data collected will include demographic information, radiological data, operative procedures and PRO data.
详细描述
The study will be conducted at UPMC St. Margaret's Hip Preservation Program. Consented patients who undergo acetabular labral repair and femoroplasty will be included in randomization of weight-bearing status. Two separate protocols will be created to indicate weight bearing status, either WBAT immediately post-op or FFWB immediately post-op, to distribute to rehabilitation staff to ensure compliance. Immediately after the surgical procedure, the surgeon will be blinded and a randomized pamphlet with post-operative instructions with weight bearing education will be given to PACU nursing staff to educate patients and fit crutches.
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 (Care Provider, Outcomes Assessor)
盲法说明
Physician performing surgical intervention will be blinded from surgery until first follow up. Also, physician performing ultrasound evaluation of hip capsule will remain blinded to weight bearing designation.
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>= 12 years
- •Diagnoses: femoroacetabular impingement and hip labral tears.
- •Surgical procedures performed: Hip arthroscopy with femoroplasty and labral repair.
- •Surgery completed at UPMC Children's or UPMC St. Margaret's Hospital
- •unilateral and bilateral hip patients
排除标准
- •MSK tumor-related FAI or dysplasia
- •generalized hypermobility
- •revision surgeries
研究组 & 干预措施
Weight bearing as tolerated (WBAT) immediately following surgery.
Subjects will be able to self-select weight bearing based on pain and confidence in surgical hip.
干预措施: Weight Bearing as tolerated (WBAT) immediately following surgery. (Other)
Flat foot weight bearing (FFWB) for 2 weeks after surgery.
Subjects will be limited to FFWB, approx 20lbs through the surgical hip.
干预措施: Flat foot weight bearing (FFWB) immediately following surgery (Other)
结局指标
主要结局
International Hip Outcome Tool 12 (iHot-12)
时间窗: up to 6 months post-operative
Scoring ranges from 0-100 * each question is rated from 0-100 and final score is the mean of all questions answered by subject * higher scoring indicating higher quality of life due to hip function
Hip and Groin Outcome Score (HAGOS)
时间窗: up to 6 months post-operative
This outcome includes 6 subscales, these are scored independently, and no aggregate scoring is calculated as each section assesses different dimensions separately. Subscales (raw scores for each subscale converted to a 0-100 scale with higher score indicating higher level of function): * Pain * Symptoms * Activities of Daily Life * Function in Sport and recreation * Participation in Physical Activities * hip and groin-related quality of life
Hip Outcome Score (HOS) ADL
时间窗: up to 6 months post-operative
Outcome assessing function with activities of daily living. Higher score is given for higher level of function and lower score indicating reduced function. 0-68 aggregate scoring converted to 0-100 scale.
Tampa Scale for Kinesiophobia-11
时间窗: up to 6 months post-operative
Outcome measure assessing fear of pain with movement. Scores range from 11 to 44. Higher scores indicate greater fear of movement
Hip Outcome Score (HOS) Sport
时间窗: up to 6 months post-operative
Outcome assessing function/difficulty completing dynamic activities associated with sports participation. Higher score is given for higher level of function and lower score indicating reduced function. 0-36 aggregate scoring converted to 0-100 scale.
次要结局
- Isometric strength measures hip add, abd, ER, and extension(6-week, 3 months, and 6-month post-operative)
- Diagnostic ultrasound assessment of bilateral anterior hip capsule thickness(3 months post-operative)
- Diagnostic ultrasound assessment of incision widening(3 months post-operative)
- Diagnostic ultrasound for focal echogenic adhesions(3 months post-operative)
- Isometric strength measures hip add, abd, ER, and extension(6-week, 3 months, and 6-month post-operative)
- Diagnostic ultrasound assessment of bilateral anterior hip capsule thickness(3 months post-operative)
- Diagnostic ultrasound assessment of incision widening(3 months post-operative)
- Diagnostic ultrasound for focal echogenic adhesions(3 months post-operative)
研究者
Craig Mauro
Clinical Associate Professor
University of Pittsburgh