Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Prevention of surgical intervention questionnaire
研究概览
简要总结
Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.
Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.
Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.
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
- •Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.
排除标准
- •Age less than 18 y/o
- •Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
- •Previous knee surgery
- •Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
- •known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions
研究组 & 干预措施
Observational
Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty.
Physical Therapy
Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures.
干预措施: Physical Therapy (Procedure)
结局指标
主要结局
Prevention of surgical intervention questionnaire
时间窗: 12 weeks
Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.
次要结局
- PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score(12 weeks)