NCT03341442已完成不适用
Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- Dislocation Rate
研究概览
简要总结
The purpose of this study is to perform a randomized controlled study to compare patients undergoing THA via a posterolateral approach to receive either standard of care post-surgery hip restrictions or to receive no restrictions. The investigators goal is to first complete a pilot study in which the investigators assess the short term dislocation rates 3-6 months and then continue to recruit into this study and follow these patients for a year to determine the 1 year risk for dislocation. The investigators also will compare the HOOS Jr. and VAS scores and time until free from walking aid. The research question is: Will the elimination of post operative posterior hip precautions increase the dislocation rate? The hypothesis is that the elimination of post operative hip precautions will not increase the dislocation rate.
详细描述
- Participants at the following institutions (West Virginia University; The Andrews Institute; and University of Kentucky Healthcare Sports Medicine will be given an educational session regarding hip replacement and procedures to follow after total hip replacement at their History and Physical visit prior to elective total hip replacement surgery via a posterior approach. 2. Participants will be told of the study after their educational session. All their questions will be answered and they will be given the opportunity to consent for participation. 3. After consent, the participant will be randomized to a control group receiving Standard of Care (education) hip precautions or to a 'no hip precautions' group. The control group will be instructed to practice postoperative hip precautions they learned at their educational session; (standard of care) (no flexion > 90 degrees, no internal rotation, no adduction) for 6 weeks. The intervention group will be aware of the precautions but will be told not to practice them post-operatively. 4. The participants will be monitored per the surgeons' normal routine post-operatively, which includes notification to the surgeon if the subject returns to the hospital with any hip problems. 5. After the first three participants who were randomized to 'no precautions' have returned for their post-op visit at all sites, the DSMB will have a teleconference to discuss any adverse events including dislocations. If any of the first 3 participants dislocated the study will be stopped. 6. At six weeks the following will be recorded: time to elimination of walking aids, dislocation episodes requiring closed reduction, and need for revision surgery. If any of the first 3 intervention participants dislocated during the 6 week period, the study will be stopped. 7. The participants will be asked to complete the HOOS Jr. and VAS follow-up questions at 2-week, 6-week, 3 month, 6 month and one year post-operatively per standard of care follow-up. Participants will be asked to list any hip precautions practiced at these time frames. 8. If the participants fail to come for the standard of care follow up appointments, the research assistant will call the participants and ask the HOOS Jr. and VAS questionnaires over the phone and to list any hip precautions they practiced.
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
- 是
入选标准
- •scheduled for elective, primary, osteoarthritic total hip arthroplasty via a posterolateral approach
排除标准
- •< 18 years of age, cognitive disorders, neuromuscular spasticity disorders, femoral neck fractures, connective tissue disorders (ie Ehlers Danlos), alcohol abuse, dual mobility implant, constrained implants, pregnant or planning to become pregnant at time of consent.
结局指标
主要结局
Dislocation Rate
时间窗: up to 1 year post op
Occurrence of dislocations will be compared between groups.
次要结局
- HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)(up to 1 year post op)
- Visual Analog Scale (VAS)(up to 1 year post op)
- Time free from walking aid(up to 1 year post op)
- Hip Precautions Practiced(up to 6 week post-op)
研究者
Matthew Dietz, MD
Assistant Professor
West Virginia University
研究点 (2)
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