Determining the Effects of Implant Design, Soft Tissue Balance, Neuromuscular Adaptations, and Rehabilitation Strategies on Functional Outcomes and Patient Satisfaction After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 8
- 主要终点
- Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA
研究概览
简要总结
In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. The investigators will prospectively study the effects of these factors using in vivo assessments preoperatively, and postoperatively. Computer simulation models will also be used to analyze lower extremity biomechanics.
详细描述
Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in 5 patients are dissatisfied with the postoperative outcome, and knee instability remains one of the top indications for revision surgery. Implant design, soft tissue balance, neuromuscular capabilities, and rehabilitation strategies can all influence postoperative outcomes. However, the relationship between these factors and the most effective therapeutic approach for total knee arthroplasty has yet to be identified. The investigators will study preoperative and postoperative functional measures and patient satisfaction along with implant design and specific intraoperative data, which may help inform a targeted approach for optimal outcomes after total knee arthroplasty and improve future care of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participant, outcome assessor
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring unilateral TKA for knee osteoarthritis
- •No osteoarthritis symptoms in contralateral knee
- •Radiographic coronal deformity ≤ 15°
- •Preoperative flexion ≥ 90°
- •Receiving one of four implants used by UF Orthopaedic surgeons
- •Able to walk for a short distance without the use of ambulatory aids
- •Healthy Participants:
- •Age 49-85 years
- •Healthy with no signs or symptoms of lower limb arthritis or injury
- •Able to walk for a short distance without the use of ambulatory aids
排除标准
- •BMI > 40 kg/m2
- •Presence of knee, hip, or ankle prosthesis for either limb
- •Presence of hip prosthesis in surgical limb (TKA only subjects)
- •History of lower limb or spinal surgery within the last year
- •Presence of neurologic or orthopaedic disorders that could affect gait or balance
- •Chronic opioid or illicit drug use
- •Poorly controlled diabetes (HbA1C > 7 percent)
- •Chronic pain syndrome
- •Chronic back pain
- •Presence of vestibular disorder
- •Pregnancy
结局指标
主要结局
Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA
时间窗: Tested preoperatively, and once during the two to four months after TKA
Maximum isometric quadriceps, hamstrings, and gluteus medius strength as measured by a dynamometer.
Top declined walking speed before and after TKA.
时间窗: Tested preoperatively, and once during the two to four months after TKA
Top walking speed is defined as the maximum speed a patient feels that they can safely walk without running. Patients will walk on an instrumented treadmill declined at seven degrees.
次要结局
未报告次要终点