Return to Play After Anterior Cruciate Ligament Reconstruction With Bone Marrow Aspirate, Demineralized Bone Matrix, and an Internal Brace
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Biomechanics testing
研究概览
简要总结
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
详细描述
At the pre-operative appointment, patients will be informed of the research study and have the option to participate. After informed consent, research subjects will provide baseline characteristics via survey from Code. This will include demographics (name, age, date of birth, height, weight, body mass index, smoking status, laterality, mechanism of injury, sport participation) and baseline PROs [International Knee Documentation Form (IKDC) Subjective Knee Evaluation Form, Knee injury and Osteoarthritis Outcome Score (KOOS) Global, Marx Activity Scale, visual analogue scores (VAS) pain, and ACL-Return to Sport Index (RSI) scores]. Data from pre-operative physical exam will also be collected.
Procedural outcomes including graft type, length, and tunnel size will be recorded. Operative time, concomitant pathologies, surgical complications will also be recorded. In addition, costs of the procedure, including surgeon fee, facility fee, and facility cost: charges ratio will be recorded.
RTS evaluation will occur at 3-, 4-, 5-, 6-, 9- and 12-months and results will determine readiness to RTP by Limb Symmetry Index (LSI) equal or greater than 85% in biomechanical testing (see below).
At 6 months, all subjects will undergo magnetic resonance imaging (MRI) of the operative extremity to investigate bone healing between groups. Imaging for this time-point is paid for by the grant/sponsor; there is no cost to the subject, and it is NOT submitted to insurance.
Primary outcomes will include results of RTS tests in FACL and control groups, RTS rates and timelines after FACL reconstruction, and re-injury rates within 2-years post-operatively. Secondary outcomes will include radiographic outcomes (bone tunnel enlargement), patient-reported outcomes (IKDC, KOOS Global, Marx activity, VAS pain, and ACL-RSI). Complications, total re-operations, and revisions ACL reconstruction rates will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA: All patients must meet the following criteria:
- •Patients must be age 14-26 years old.
- •Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.
- •Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity
- •Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded.
- •An understanding of the purpose of the study and providing written informed consent.
排除标准
- •EXCLUSION CRITERIA:
- •Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
- •Patients who have undergone previous ACL reconstructive surgery.
- •Patients who are currently pregnant or nursing.
- •Patients who have a current infection at the operative site.
- •Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
结局指标
主要结局
Biomechanics testing
时间窗: 4.5 months after surgery and 6 months after surgery
Patient will undergo hop testing for limb symmetry
Return to play
时间窗: 6 months after surgery until study conclusion
Patient will be monitored for return to play at their sport
次要结局
- MRI findings(6 months after surgery)