Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Side to side difference in laxity as measured by the KT-1000 Arthrometer
研究概览
简要总结
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ACLR with BTB autograft
- •Patients ages 18-35, inclusive
- •Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee
排除标准
- •Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
- •Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
- •History of autoimmune or inflammatory disease
- •Prior ipsilateral knee ligament surgery or multi-ligament knee injury
- •Concomitant Lateral extra-articular tenodesis (LET) procedure
- •History of contralateral ACL surgery
- •Younger than 18 years of age
- •Older than 35 years of age
研究组 & 干预措施
Internal Brace
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.
干预措施: Arthrex Internal Brace (Device)
Internal Brace
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.
干预措施: ACL Reconstruction (Procedure)
Standard ACLR
Patients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.
干预措施: ACL Reconstruction (Procedure)
结局指标
主要结局
Side to side difference in laxity as measured by the KT-1000 Arthrometer
时间窗: Month 24 Post-Operation
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.
Side to side difference in laxity as measured by the KT-1000 Arthrometer
时间窗: Month 12 Post-Operation
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.
次要结局
- Pivot Shift Grade(Month 24 Post-Operation)
- Tegner Activity Level Scale(Month 24 Post-Operation)
- Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation(Baseline, Month 24 Post-Operation)
- Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation(Baseline, Month 24 Post-Operation)
- Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation(Baseline, Month 12 Post-Operation)
- Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation(Baseline, Month 12 Post-Operation)
- Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation(Baseline, Month 24 Post-Operation)
- Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation(Baseline, Month 12 Post-Operation)
- Pivot Shift Grade(Month 12 Post-Operation)