Bone Tunnel Widening Following ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Bone Tunnel Diameter
研究概览
简要总结
Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts.
Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the tendon remodels within the bone tunnels.
Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.
详细描述
This will be a prospective study for patients undergoing ACL reconstruction using bone-patella tendon-bone graft, hamstring graft or achilles allograft. Each group will have ACL reconstruction with fixation using bioabsorbable interference screws on the femoral and tibial side. Patients will be evaluated on the day of surgery, 6, 12, 24, 52 and 104 weeks post-operatively. Evaluations will include pre-operative regional and standard bone mineral density measurements, post-operative MRI evaluation of tunnel dimensions and bone-tendon interface, radiographic evaluation of tunnel dimensions and routine clinical follow-up.
Interventions or Observations - outline specific procedures, treatments and/or interventions, as well as sources of research material to be utilized, which will involve human subjects or human materials that will be part of this research project.
This study will require a pre-operative bone mineral density measurement in the Nuclear Medicine Division of the Department of Radiology at HSS. Standard measurements of the femoral neck, spine as well as regional studies of the distal femur and proximal tibia of the injured knee will be performed.
On the day of surgery, the patient will undergo ACL reconstruction using bioabsorbable interference screw fixation of the hamstring, bone-patella tendon-bone graft, or achilles allograft. This is a standard procedure. The choice of graft type (hamstring, bone-patella tendon-bone graft, or achilles allograft) will be discussed with the patients and the patient will decide graft type pre-operatively. In this study, we will standardize the fixation method by using bioabsorbable interference screws. Post-operatively, the patient will undergo a limited MRI scan to evaluate the tunnel dimensions as well as graft placement prior to discharge from the hospital.
During the patients' 6 weeks, 12 weeks and 24 weeks clinical follow-up, they will be evaluated by their orthopaedic surgeon for clinical progress. Standard radiographs will be obtained of the patient's knee at the 6 weeks and 24 weeks follow-up visit. These are standard radiographic evaluations and are of no additional charge to the patients. We will utilize these images for radiographic measurements of tunnel expansion. During these visits, the patients will also undergo limited MRI scan of the femoral tunnel and tibia tunnel. With the serial MRI images, we will be able to make accurate measurements of the femoral and tibial tunnels. In addition, we will be able to evaluate the bone-tendon interface as well as the maturation of the intra-articular portion of the ACL graft. At 24, 52 and 104 weeks the patients will also be given standard IKDC and Lysholm clinical knee outcome questionnaires and will have objective stability measurements of both the operative and non-operative knees using a KT-1000 instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals within the age range of 18 to 55 years who are diagnosed with anterior cruciate insufficiency and have decided to undergo ACL reconstruction using autogenous graft will be included in the study.
排除标准
- •Individuals that have previous knee surgeries, multi-ligament injuries, systemic ligament disorders such as Ehlers Danlos syndrome or connective tissue disorders will be excluded from the study.
- •Individuals who are pregnant or expect to be pregnant during the course of the study or who are especially concerned with X-ray exposure should also be excluded.
结局指标
主要结局
Bone Tunnel Diameter
时间窗: 2 years
Bone tunnel diameter measured on MRI
次要结局
未报告次要终点
