椎間盤退化症為人類自然老化的症狀，隨著老年人口增加，患病數隨之上升，另外也會因工作或姿勢不良等，增加椎間盤退化的風險與速度，其中又以腰椎發生病變的機率最高，進而導致慢性下背痛。
臨床上，一般先以保守治療3至6個月，若症狀沒有改善或加重，則需透過手術來緩解，而腰椎融合手術即為其中一種手術治療。近年來，以微創腰椎融合手術最為普遍，此法是透過縮小傷口以降低如減少失血量與肌肉損傷等之傷害，，同時也可以搭配骨填充物改善融合率與術後的生活品質。臨床上，現行的標準療法是以取自髖骨之自體骨做為骨填充物，可達極高的融合率，但礙於取骨處有感染風險、疼痛並延長手術時間，甚至有取骨量不足的問題，故人工合成骨或複合性藥物等已逐漸取代髖骨自體骨做為新一代的骨填充物。
臨床試驗在新藥開發流程中扮演關鍵且重要的角色，藥物的有效性和安全性需經由臨床試驗來驗證，透過嚴謹的臨床試驗設計，如受試者納入排除條件、隨機分派、盲性等；良好的試驗設計，可以確保試驗結果的可信度、降低受試者的風險，並提高試驗的成功率。
本試驗設計針對椎節L1至S1患有椎間盤退化之病患，利用一複合性醫材 (三鈣磷酸鹽β-TCP與生長因子E.rhBMP-2)，搭配微創手術進行治療，以期縮短融合時間並達到良好的融合率。依據臨床試驗設計之考量，針對複合性藥物應用於椎間盤退化症，設計一隨機、評估者盲性、對照之醫療器材樞紐性臨床試驗。
Disc degenerative disease (DDD) occurs with aging in humans. As the number of elderly people increases, the number of disc degenerative illnesses increases as well. The increased risk and speed of disc deterioration is caused by work, daily habits, or poor posture. Lumbar spine disc degeneration is relatively common and leads to chronic low back pain.
Conservative, non-invasive approaches are typically used as the first-line treatment for patients with DDD. Surgical treatments may be necessary if symptoms of lumbar DDD persist for 3–6 months in spite of these non-operative treatments. Lumbar spine interbody fusion is one of the surgical treatments for lumbar DDD. Minimally invasive fusion surgery has been commonly used in recent years, and it reduces blood loss and muscle damage by minimizing incision size. Furthermore, minimally invasive fusion surgery with bone grafts can improve fusion rate and quality of life during recovery. Iliac crest bone grafts (ICBGs) remain the “gold standard” treatment; however, patient dissatisfaction has been encountered due to donor-site morbidity, lengthier operating times and finite supply of ICBGs. Synthetic bone graft materials or combination products may be an alternative to bone grafts, with an efficacy that equals or exceeds that of autografts.
Clinical trials play an important role in developing new drug. The safety and efficacy of interventions must be proved by well-designed clinical trials. Fundamental considerations include enrollment criteria, randomization and blinding and so on. Moreover, a well-designed clinical trial can protect the subjects, minimize the risk of bias, and improve the success rate.
This study focuses on patients with single-level (between L1 to S1) DDD using a combination product (Escherichia coli expressed bone morphogenetic protein 2/β-Tricalcium phosphate) with the interbody cage through minimally invasive surgery transforaminal lumbar interbody fusion (MIS-TLIF). We designed a randomized, evaluator-blinded, controlled pivotal clinical trial for the treatment of lumbar DDD. We believe that this procedure has potential benefits such as a short fusion time and a high fusion rate compared to autografts.
