Does Bone Grafting at the Time of Bone-Patellar Tendon-Bone ACL Reconstruction Reduce the Incidence of Post-operative Anterior Knee Pain: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Visual Analog Scale
研究概览
简要总结
It is estimated that 48 out of 10,000 people, in the United States, will tear their anterior cruciate ligament (ACL) annually and undergo ACL reconstruction (ACLR). Surgeons have several graft options, surgical techniques, and fixation methods to consider when planning how to reconstruct a patient's ACL. Graft options vary greatly and include allografts and autografts with good evidence that are good choices. Further, autografts include several different specific grafts including; bone-patellar tendon-bone (BPTB), hamstring tendons, and quadriceps tendon. There is no clear consensus on which graft type is superior, as each graft has associated positives and negatives.
Historically, autologous BPTB grafts have been the preferred choice of surgeons given its ability to restore rotational stability for the knee, the robust healing with direct bone-to-bone contact at both ends of the graft, and low failure rates. However, there are drawbacks to ACLR using a BPTB graft. Complications following BPTB graft harvesting include patella fractures, patellar tendon ruptures, increased risk of patellofemoral osteoarthritis, lack of terminal extension, and donor-site morbidity. The majority of these complications are associated with low-risk rates, except for donor-site morbidity which may be prevalent in 37-51% of BPTB graft patients. Donor-site pain can manifest as anterior knee, patellofemoral pain, loss of sensory input, or discomfort with kneeling and can negatively influence subjective as well as objective measures of knee function.
Filling bony defects with bone graft is a procedure that is commonly conducted within orthopedics. However, its use in treating the bony defects caused during BPTB graft harvesting is less common as patella and tibial harvest sites are routinely left unfilled. Significant methodological differences in treatment interventions for the patella harvest site, the tibial harvest site, or both and conflicting results have made it difficult to determine if these treatments have clinical utility. To the best of the investigators' knowledge, there has been no investigation looking at the incidence of donor site morbidity treated with autologous bone grafting of the harvest sites. Therefore, the purpose of this study is to determine if filling the harvest site defect is associated with a lower rate of donor site morbidity and better patient reported functional outcomes compared to patients whose harvest site remains unfilled.
The purpose of this study is to compare the rate of donor site morbidity between patients who have their harvest sites bone grafted with autologous bone (BG) and those whose harvest sites remain unfilled (nBG).
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •18 years of age and older, with no upper age limit
- •A candidate for primary autologous BPTB ACLR
- •Willing to participate in the study
排除标准
- •Concomitant ligamentous or chondral injury
- •Prior surgery on the index knee
- •Prior history of anterior knee pain or patellofemoral joint pain on the index knee
- •Outerbridge classification > 2 assessed during arthroscopy
结局指标
主要结局
Visual Analog Scale
时间窗: post-op month 24
The Visual Analog Scale (VAS) is a 10-cm line that allows subjects to visually report their pain between "no pain" (0 cm) on the left and "constant pain" (10 cm) on the right. Patients will be asked to complete the VAS with the prompt, "Please indicate the amount of pain you are feeling right now in the front of your knee." It is considered a worse outcome the closer the patient marks to the "constant pain" on the right of the scale.
Pain with Kneeling
时间窗: post-op month 24
Subjects will also be asked to kneel on the floor of the examination room and rate their pain as either 'no pain', 'mild pain', 'unable to kneel on hard surface but able with cushion/pad', or 'complete inability to kneel'. 'Complete inability to kneel' is considered the worst outcome within this measure, with the following considered increasing better outcomes in this order: 'unable to kneel on hard surface but able with cushion/pad', 'mild pain', 'no pain'.
Direct Palpation of Harvest Site
时间窗: post-op month 24
Subjects will be asked to rate their pain as either 'no pain', 'mild pain' or 'sharp pain' during direct palpation for both the patella and tibial harvest sites. 'Sharp pain' is considered the worse outcome, 'mild pain' as a median outcome, and 'no pain' is considered the best outcome of the three.
次要结局
- PROMIS-10(post-op month 24)
- Marx Activity Scale(post-op month 24)
- Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF)(post-op month 24)
- International Knee Documentation Committee (IKDC) Subjective form(post-op 24)
