Will Visual Affirmation of Knee Range of Motion (ROM) Affect Patient Outcomes in Patients Undergoing a Primary Total Knee Arthroplasty (TKA)? A Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Knee Society Score
研究概览
简要总结
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary TKA after photographing final knee range of motion immediately post-operatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph.
详细描述
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary total knee arthroplasty (TKA) after photographing final knee range of motion immediately postoperatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph. The knee will be photographed in maximum flexion and extension. The primary objectives will be to compare the range of motion of the operative knee at 2 weeks and 6 weeks postoperatively. In the investigator's institution, patients who have failed to achieve 90 degrees of flexion at a postoperative period of 6 weeks undergo manipulation of the knee under anesthesia (MUA). The investigators will also measure how many patients require MUA in the photograph group and non-photograph group. MUA will be performed if patients fail to achieve 90 degrees of flexion at 6 weeks post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between the age of 22-89
- •Patient is scheduled to undergo a unilateral, cementless primary TKA, secondary to osteoarthritis
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
- •Patient is able to read and speak English.
排除标准
- •Patient is under the age of 22 or over the age of 89
- •Patient has preoperative stiffness/contracture of the knee secondary to post-traumatic arthritis
- •Patient is scheduled to undergo a bilateral TKA surgery
- •Patient is unable to read and speak English
研究组 & 干预措施
A - will be shown their photograph at 2 weeks post-operative.
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
干预措施: Patient will be shown a photograph of their knee at 2 weeks postop (Other)
B - will not be shown their photograph
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will not be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
干预措施: Patient will not be shown a photograph of their knee at 2 weeks postop (Other)
结局指标
主要结局
Knee Society Score
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
WOMAC Score
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
Active range-of-motion (ROM)
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
total length of hospital stay
时间窗: outcome measure will be taken at 2 weeks postoperatively
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Operative Time
时间窗: outcome measure will be taken at 2 weeks postoperatively
Total Operative Time as defined in minutes
Tourniquet time
时间窗: outcome measure will be taken at 2 weeks postoperatively
Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Loss of knee motion is defined as failure to achieve greater than 100 degrees of active flexion. Manipulation under anesthesia is an outpatient procedure performed by orthopedic surgeon to help improve patient's range-of-motion.
Estimated Blood Loss (EBL)
时间窗: outcome measure will be taken at 2 weeks postoperatively
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
Knee Society Score
时间窗: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
WOMAC Score
时间窗: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
Active range-of-motion (ROM)
时间窗: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
次要结局
- Number of Participants with postoperative complications(outcome measure will be taken 6 weeks (± 2 weeks) postoperatively)
研究者
Arthur Malkani
Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery
University of Louisville