Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Time to full symmetric extension
研究概览
简要总结
This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. This will be directly measured with goniometric angle and heel-height measurements relative to the contralateral side. Other metrics will include standard, validated patient reported outcomes and requirements for additional interventions to treat extension deficits including, but not limited to, additional therapy, intraarticular injections, oral corticosteroids, manipulation under anesthesia, or arthroscopic arthrolysis.
详细描述
This study will be a prospective randomized controlled trial of patients undergoing arthroscopic reconstruction of full thickness ACL tears with bone-patellar tendon-bone autograft. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms.
Subjects will be appropriately fitted for the brace corresponding to randomization on the day of surgery. All braces will be placed on the subject in the operating room at the conclusion of the procedure. All patient will begin a standardized physical therapy protocol on postoperative day 1-14.
Follow-up will take place at standard of care office visits at 1-week, 2-week, 6-weeks, 12-weeks, and 6-months. Range of motion, including goniometric angle and heel-height measurements, will be recorded at all postoperative time points. Time-to-achievement of full symmetric extension relative to the non-surgical knee will be monitored and recorded. At 3, 6, and 12 months, patients will also be asked to complete standardized, patient-reported outcomes questionnaires including IKDC, KOOS, PROMIS, VAS pain, VR/SF 12, and brief resilience scale. Patients will also be asked to answer questions regarding return to work and return to sport throughout the 1-year postoperative period.
Both treatment groups will progress according to standardized, postoperative rehabilitation programs, similar to the program outlined below.
Phase I: Protection, Range of Motion (ROM), and Proprioception
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ACL Reconstruction
- •No associated repair or reconstruction procedures (meniscal repair, other ligamentous pathology). Patients undergoing concurrent partial meniscectomy would be eligible for inclusion.
- •Clinical and radiographic examination (MRI), performed as standard of care prior to study enrollment, consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
- •Written and informed consent for study participation
排除标准
- •Patients younger than 18 or older than 40 years of age
- •Revision surgery or prior history of knee surgery
- •Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- •Inability to comply with the proposed follow-up clinic visits
- •Patients lacking decisional capacity
- •Pregnant or breast-feeding women
- •Worker's compensation patients
- •Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
结局指标
主要结局
Time to full symmetric extension
时间窗: Up to 6 months postoperatively
Time-to-achievement of full symmetric extension relative to the non-surgical knee
Range of motion
时间窗: 6 months postoperatively
Includes heel-height measurements
次要结局
未报告次要终点