Effects of Initial Graft Tension on ACL Reconstruction

移植物初始张力对 ACL 重建的影响

• 批准号: 7657961
• 负责人: Braden C Fleming
• 金额: $ 34.3万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7657961
• 关键词: Affect; Anterior; Anterior Cruciate Ligament; Arthritis; Autologous Transplantation; Biological Markers; Cadaver; Caring; Cartilage; Clinical; Clinical Research; Contralateral; Control Groups; Controlled Study; Data; Degenerative polyarthritis; Diagnostic radiologic examination; Disease; Disease Progression; Double-Blind Method; Early Diagnosis; Economic Burden; Enrollment; Epidemic; Evaluation; Femur; Funding; Future; Healed; Humulus; Image; Incidence; Injury; Investigation; Isotonic Exercise; Joints; Knee; Knee Injuries; Knee Osteoarthritis; Knee joint; Ligaments; Long-Term Effects; Magnetic Resonance Imaging; Magnetism; Measures; Mechanics; Methods; Modification; Motion; Operative Surgical Procedures; Organ; Outcome; Outcome Measure; Patients; Population Control; Progress Reports; Protocols documentation; Randomized; Recruitment Activity; Relative (related person); Risk; SF-36; Staging; Stress; Structure; Techniques; Testing; Thick; Time; Tissues; Traumatic Arthropathy; Weight-Bearing state; Width; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; articular cartilage; base; design; follow-up; functional restoration; graft healing; healing; high risk; in vivo; injured; kinematics; ligament injury; patient oriented; patient population; prevent; primary outcome; prospective; public health relevance; reconstruction; response; sample fixation; secondary outcome; tibia

DESCRIPTION (provided by applicant): Disruption of the anterior cruciate ligament (ACL) is a common injury that usually requires surgical reconstruction to restore function and prevent the progression of post- traumatic osteoarthritis (OA). However, evidence suggests that OA persists despite surgery. The initial tension applied to the graft at the time of surgery controls knee motion and the distribution of joint contact stress, factors thought to induce OA. Our primary objective is to evaluate the effects of initial graft tension on the articular cartilage response following ACL reconstruction in a prospective, randomized, double-blinded controlled study. Patients who were candidates for ACL reconstruction with an autograft were randomized into one of two treatment groups: 1) initial graft tension set such that the anterior-posterior (A-P) laxity of the reconstructed knee is equal to that of the contralateral normal knee (the "low-tension" treatment), and 2) initial graft tension set to reduce A-P laxity by 2-mm relative to that of the contralateral knee (the "high-tension" treatment). An additional group of subjects without evidence of knee injury was recruited to serve as a control. In the current funding cycle, the short-term outcome (<3 years) is being assessed. In this competitive renewal, the follow-up will be extended to a minimum of 7-years. The long-term follow-up is necessary to clearly identify those patients who will present with osteoarthritis. Joint space narrowing via radiography is the only validated measure for quantifying OA progression, and will continue to serve as the primary outcome measure for the study. Quantitative and semi-quantitative MRIs will also be used to assess cartilage volume loss and the integrity of related tissues. The effects of initial graft tension will also be assessed using the secondary outcome measures of A-P laxity (an indicator of graft integrity and knee kinematics), isokinetic strength (an indicator of dynamic function), and validated patient-oriented and clinical outcome scores. We hypothesize that after 7-years of healing, the tibiofemoral joint space width and cartilage thickness in the reconstructed knees of the "high-tension" treatment group will be equal to those of the control group, while that of the the "low- tension" treatment group will be less than those of the control group (indicating OA). We also expect that those patients with increased laxity following surgery will be more prone to osteoarthritis. The relationships between the different outcome measures will also be assessed. PUBLIC HEALTH RELEVANCE: ACL injuries have reached epidemic proportions and place the patient at high risk for post-traumatic arthritis. The proposed study will establish the incidence of arthritis following knee ligament surgery, and will determine if a modification in the surgical technique can reduce cartilage degeneration. It will also explore potential causes of arthritis and validate methods used to detect arthritis in the early stages of the disease. Therefore these data could impact the future care of the ACL injured patient and reduce the economic burden of post- traumatic arthritis associated with this injury.

描述（由申请人提供）：前交叉韧带（ACL）的破坏是一种常见损伤，通常需要手术重建以恢复功能并防止后创伤后骨关节炎（OA）的进展。但是，有证据表明，尽管手术是OA仍然存在的。手术时，最初的张力适用于移植物，可控制膝关节运动和关节接触应力的分布，即被认为会诱导OA的因素。我们的主要目的是评估在前瞻性，随机，双盲对照研究中，ACL重建后，初始移植张力对关节软骨反应的影响。随机分为一个治疗组之一，是候选ACL重建的候选者：1）初始移植张力组之一，使得重建的膝盖的前后 - 后方（A-P）松弛度等于对侧正常膝关节的膝盖（低应变”治疗（低应变），以及降低2-M的初始伸长量（2-MM），以降低2-MM的限制（2-MM）。 “高压”治疗）。招募了一组没有膝盖损伤证据的受试者作为对照。在当前的融资周期中，正在评估短期结果（<3年）。在这种竞争性更新中，后续行动将至少扩展到7年。长期的随访是必须清楚地识别出患有骨关节炎的患者的必要过程。通过射线照相缩小的关节空间是量化OA进展的唯一验证措施，并将继续作为研究的主要结果指标。定量和半定量MRI也将用于评估软骨体积损失和相关组织的完整性。初始移植张力的影响还将使用A-P松弛度（移植物完整性和膝关节运动学的指标），同动力强度（动态功能的指标）以及经过验证的患者和临床结果评分进行评估。我们假设经过7年的愈合，“高应变”治疗组的重建膝盖的胫骨关节空间宽度和软骨厚度将等于对照组的膝关节宽度，而“低张力”治疗组的治疗组的厚度将小于对照组（指示OA）的治疗组。我们还期望那些手术后泻药增加的患者更容易患骨关节炎。不同的结果指标之间的关系也将得到评估。公共卫生相关性：ACL受伤已经达到了流行病，并使患者处于创伤后关节炎的高风险。拟议的研究将在膝盖韧带手术后确定关节炎的发生率，并确定手术技术的修饰是否可以减少软骨变性。它还将探索关节炎的潜在原因，并验证用于检测疾病早期关节炎的方法。因此，这些数据可能会影响ACL受伤患者的未来护理，并减轻与此损伤相关的创伤后关节炎的经济负担。