Blood Flow Restriction Training Following Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- quadriceps strength
研究概览
简要总结
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.
详细描述
Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy
- •Males and females 50-79 years of age
- •Ability to consent to study enrollment
- •Able to participate fully in physical therapy
- •Tricare Beneficiary
- •Implant restricted: primary cruciate retaining or posterior stabilized total knee arthroplasty
- •Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion**
- •only screened at secondary screening
排除标准
- •Unable to consent for study participation
- •Unable to participate in preoperative testing
- •Any ligamentous or bony reconstruction performed at time of surgery that limits weight bearing or rehabilitation protocol
- •History of deep venous thrombosis
- •Injury or recent procedure to contralateral extremity within past 6 months
- •History of endothelial dysfunction
- •History of Peripheral Vascular Disease
- •Patient endorsement of easy bruising
- •Revision Total Knee Arthroplasty
- •History of Surgical wound complication on involved extremity
- •History of Cerebral Vascular Event
- •History of Dementia
- •History of Neuromuscular disorder
- •History of Chronic Obstructive Pulmonary Disease requiring oxygen supplementation or limiting participants ability to perform therapy and/or testing
- •History of previous intra-articular fracture of surgical extremity requiring open reduction and internal fixation or external fixation
- •History of Sickle cell trait and/or disease
- •Previously participated in blood flow restriction training interventions
- •Planned or unplanned additional surgical procedures affecting their ability to complete all session of physical therapy or testing during the following 6 months from their primary intervention
- •Patient reported history of functionally limiting arthritis in non-surgical lower extremity or ipsilateral hip or ankle
- •History or previous contralateral total knee arthroplasty
- •Any history of previous total hip arthroplasty
结局指标
主要结局
quadriceps strength
时间窗: baseline up to 2 years post operative
quadriceps strength via dynamometer
次要结局
- Patient reported outcome 4: Pain Visual analog score(baseline up to 2 years post operative)
- Patient reported outcome 1: KOOS(baseline up to 2 years post operative)
- Patient reported outcome 2: PROMIS Global Health(baseline up to 2 years post operative)
- Patient reported outcome 3: Promis-29(baseline up to 2 years post operative)
- Physical Outcome measure 1: Four square step test(baseline up to 2 years post operative)
- Physical Outcome measure 2: Sit to stand test(baseline up to 2 years post operative)
- Physical Outcome measure 3: 6 minute walk test(baseline up to 2 years post operative)
- Physical Outcome measure 4: Timed up and go test(baseline up to 2 years post operative)
- Physical Outcome measure 5: Timed stair ascent(baseline up to 2 years post operative)
研究者
David Tennent
Orthopaedic Surgery Resident
San Antonio Military Medical Center