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국문

추간판 탈출증에서 내시경 수술 방법이 기존 고식적 수술과 비교하여 임상적 결과의 동등성을 확인해 보고자 한다. 또한 내시경 수술의 다기관, 전향적 임상데이터를 분석하여 임상 진료 지침에 대한 근거를 마련하고, 치료법 선택에 대한 임상 진료 지침을 제시하고자 한다. 이를 위해 총 6개 기관에서 요추부 추간판 탈출증 환자에서 양방향 내시경을 이용한 추간판 절제술의 임상적 효용성 및 안정성을 기존의 고식적 미세 현미경 수술법과 비교해 보고자 한다.

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The purpose of this study is to confirm the equivalence of clinical results compared to conventional surgery for endoscopic surgery for herniated discs. In addition, by analyzing multicenter prospective clinical data on endoscopic surgery, we will prepare the basis for clinical treatment guidelines and provide clinical treatment guidelines for treatment selection. To this end, the purpose of this study was to compare the clinical efficacy and safety of discectomy with bidirectional endoscopy with conventional microscopic surgical methods in a total of 6 insitutions.

국문

본 임상시험이 시작하기 전 시험에 참여하는 모든 연구자는 임상시험용의료기기에 대한 시술방법에 합의하며, 표준화된 방법으로 시술한다. 관절경 기구와 척추 수술기구를 이용하여 추간판 절제술을 시행한다. 두 가지 기구가 들어갈 수 있으므로 양방향 척추 내시경 추간판 절제술이라 하며 Portal이 들어가는 곳만 절개선을 넣을 수 있어 정상 조직의 손상을 최소화 할 수 있다.
수술 부위 소독 이후 내시경 카메라 진입과 지속적인 관류를 위한 관찰 삽입구(viewing portal)와 감압술을 위한 기구를 삽입할 작업 삽입구(working portal)를 만든다. 위 추체의 외측 경계에서 1 cm 외측, 횡돌기의 상부 경계 높이에 하나의 입구(portal)를 만들고 약 2 cm 원위부에 두 번째 입구를 만든다. 지속적인 생리식염수 배출 및 기구 삽입을 위해 각 삽입구는 약 1 cm 길이의 피부 절개로 충분하다. 술자의 위치에서 좌측을 작업 삽입구, 우측을 시야를 위한 관찰 삽입구로 한다.
추간공에서 황색인대 근위부는 상부 척추 횡돌기와 척추경(pedicle) 원위부 표면에서 확실하게 구분된다. 목표 구획의 황색인대 절제술을 시행할 때는 상부 척추 횡돌기의 원위부 말단 아래로 주행하는 신경근을 손상시키지 않도록 주의해야 한다. 필요시 신경근 주변의 작은 혈관들의 출혈조절 후 디스크 절제술을 시도할 수 있다. 섬유륜은 indian knife로 절제하고 소파기를 섬유륜의 외막 아래로 삽입하여 파열된 디스크 조각들을 신경근 아래에서 제거하도록 한다.

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Before the start of this clinical trial, all researchers participating in the trial agree on the method of treatment for the clinical trial medical device and perform the procedure in a standardized manner.In the case of bidirectional spinal endoscopic discectomy, discectomy is performed using arthroscopic instruments and spinal surgery instruments. Since two mechanisms may be involved, it is possible to place improvement of the node only where the portal enters, which is called bidirectional spinal endoscopic discectomy, and damage to normal tissue can be minimized.
After disinfecting the surgical site, create a viewing portal for entry into the endoscopic camera and continuous perfusion and a working portal to insert instruments for decompression. Make viewing portal at the upper boundary of the transverse process, 1 cm outside of the lateral boundary of the upper vertebrae, and a working entrance at the distal of about 2 cm. For continuous saline drainage and instrument insertion, a skin incision approximately 1 cm long is sufficient for each insertion port. Following the operator's position, the left incision is used as the working portal, and the right side incision is used as the observation portal.
The proximal portion of the ligament flavum is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing ligament flavectomy at the target level, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. A discectomy may be attempted after controlling the bleeding of small blood vessels around the nerve root if necessary. The annulus of fibroblasts is excised with an Indian knife. The curette is inserted under the annulus's outer membrane to remove the ruptured disc pieces from underneath the nerve root.

상세내용 영문

Before the start of this clinical trial, all researchers participating in the trial agree on the method of treatment for the clinical trial medical device and perform the procedure in a standardized manner.In the case of bidirectional spinal endoscopic discectomy, discectomy is performed using arthroscopic instruments and spinal surgery instruments. Since two mechanisms may be involved, it is possible to place improvement of the node only where the portal enters, which is called bidirectional spinal endoscopic discectomy, and damage to normal tissue can be minimized.
After disinfecting the surgical site, create a viewing portal for entry into the endoscopic camera and continuous perfusion and a working portal to insert instruments for decompression. Make viewing portal at the upper boundary of the transverse process, 1 cm outside of the lateral boundary of the upper vertebrae, and a working entrance at the distal of about 2 cm. For continuous saline drainage and instrument insertion, a skin incision approximately 1 cm long is sufficient for each insertion port. Following the operator's position, the left incision is used as the working portal, and the right side incision is used as the observation portal.
The proximal portion of the ligament flavum is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing ligament flavectomy at the target level, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. A discectomy may be attempted after controlling the bleeding of small blood vessels around the nerve root if necessary. The annulus of fibroblasts is excised with an Indian knife. The curette is inserted under the annulus's outer membrane to remove the ruptured disc pieces from underneath the nerve root.

상세내용 영문

After disinfecting the surgical site, check the target level with simple radiography. A skin incision is made about 3 cm long along the long axis at a distance of about 1 cm from the midline of the surgery site toward the lesion. The paraspinal muscles are dissected from the spinous process, lamina, and facet joints. 
The proximal portion of the yellow ligament is clearly distinguished from the upper transverse process of the spine and the distal surface of the pedicle. When performing ligament flavumectomy in the target level, care must be taken not to damage the nerve roots running below the distal end of the upper transverse process. A discectomy may be attempted after controlling the bleeding of small blood vessels around the nerve root if necessary. The annulus of fibroblasts is excised with an indian knife. The curette is inserted under the annulus's outer membrane to remove the ruptured disc pieces from underneath the nerve root.

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Patients requiring bidirectional endoscopic discectomy or microscopic discectomy with lumbar herniation.

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Difference in ODI value after 52 weeks after surgery

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52 weeks after surgery

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EQ-5D score changes

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Before surgery, 2, 12, 24, and 52 weeks after surgery

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VAS score changes

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Before surgery, 2, 12, 24, and 52 weeks after surgery

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Walking time

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Before surgery, 2, 12, 24, and 52 weeks after surgery

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Satisfaction after surgery

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2, 12, 24, and 52 weeks after surgery

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Period to return to daily life

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2, 12, 24, and 52 weeks after surgery

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POSAS questionnaire

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12, 24, and 52 weeks after surgery

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Radiological evaluation

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Before surgery, 2, 12, 24, and 52 weeks after surgery