Surgical Treatment of Adjacent Segment Stenosis (STASS)
2026년 6월 18일 업데이트: Anton Früh, Charite University, Berlin, Germany
The goal of this clinical trial is to learn whether microdecompression alone is as effective as decompression with extension of fusion surgery in patients with symptomatic adjacent segment stenosis after previous lumbar fusion surgery.
The main questions it aims to answer are:
Is microdecompression alone non-inferior to decompression with extension of fusion in improving disability 24 months after surgery, as measured by the Oswestry Disability Index (ODI)? Does microdecompression alone result in similar or lower rates of complications, reoperations, pain, and radiological progression compared with decompression and fusion?
Researchers will compare microdecompression alone to decompression with extension of lumbar fusion to determine whether the less invasive procedure can achieve similar clinical outcomes while reducing surgical burden and preserving spinal structures.
Participants will:
Be randomly assigned to one of two treatment groups: microdecompression alone or decompression with extension of lumbar fusion.
Undergo the assigned surgical treatment. Attend clinical and radiological follow-up visits at 6, 12, and 24 months after surgery.
Complete questionnaires assessing disability, pain, quality of life, sleep quality, and mental health.
Undergo routine imaging and clinical examinations to evaluate treatment outcomes and possible complications.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
338
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Anton Früh, PD MD M.Sc.
- 전화번호: +49 030 450 660 376
- 이메일: anton.frueh@charite.de
연구 장소
-
-
State of Berlin
-
Berlin, State of Berlin, 독일, 10117
- Charité - Universitätsmedizin Berlin
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ≥18 years.
- Oswestry Disability Index (ODI) between 30% and 80% at screening.
- Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery.
- Persistent symptoms despite at least 6 weeks of appropriate conservative treatment.
- Radiological evidence of adjacent segment spinal stenosis on magnetic resonance imaging (MRI).
- Ability to understand the study procedures and complete patient-reported outcome questionnaires.
- Ability to provide written informed consent.
Exclusion Criteria:
- Adjacent segment kyphosis or scoliosis greater than 10 degrees.
- Screw loosening or pseudarthrosis of the previous fusion construct.
- Known current pregnancy or breastfeeding.
- Acute traumatic spinal injury or fracture.
- Active inflammatory disease of the spine.
- Active neoplastic disease of the spine.
- Contraindication to spinal surgery.
- Inability to provide informed consent or complete study questionnaires.
- Symptoms attributable to spinal stenosis are not the predominant clinical complaint
- Foraminal stenosis grade ≥2 according to the Lee classification.
- Dynamic spondylolisthesis ≥3 mm on flexion-extension radiographs.
- Persons involuntarily detained by judicial or administrative order.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Control
Decompression and fusion
|
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
|
|
활성 비교기: Intervention
Mircosurgical decompression only
|
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
기간: 24 months after surgery
|
The primary endpoint is the proportion of participants achieving a reduction of at least 30% in the Oswestry Disability Index (ODI) compared with baseline.
The ODI is a validated patient-reported outcome measure assessing disability related to lumbar spine disorders on a scale from 0% to 100%.
A reduction of at least 30% is considered clinically meaningful.
|
24 months after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain related disability
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Disability related to low back pain assessed using the Oswestry Disability Index (ODI).
The ODI score ranges from 0 to 100%, with higher scores indicating greater disability and worse functional impairment.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Leg Pain Intensity at Rest
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Leg Pain Intensity during Movement
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain during movement.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Back Pain Intensity at Rest
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for back pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Back Pain Intensity during Movement
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for back pain during movement.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Maximum Walking Distance
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Maximum walking distance measured in meters.
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
generates eight domain scores (physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health), each transformed to a scale ranging from 0 to 100, with higher scores indicating better health-related quality of life and functional status.
Unit of Measure: Points on a scale (0-100).
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The EQ-5D-5L evaluates five dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels.
Responses are converted into a single EQ-5D-5L Index Score using an established country-specific value set.
Higher index scores indicate better health-related quality of life.
Unit of Measure: Utility index score (higher scores indicate better health-related quality of life).
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Mood Assessed by the German General Depression Scale - Short Form (ADS-K)
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Depressive symptoms assessed using the German General Depression Scale - Short Form (ADS-K).
The ADS-K is a self-report questionnaire comprising 15 items, each rated on a 4-point Likert scale (0-3 points).
Total scores range from 0 to 45 points, with higher scores indicating more severe depressive symptomatology and worse mood status.
Unit of Measure: Points on a scale (range: 0-45; higher scores indicate more severe depressive symptoms)
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
기간: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI is a self-administered questionnaire evaluating sleep quality and disturbances over the previous month across seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Component scores are summed to generate a global PSQI score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality and greater sleep disturbance.
Unit of Measure: Points on a scale (range: 0-21; higher scores indicate worse sleep quality).
|
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
|
|
Length of hospital stay
기간: From date of surgery until hospital discharge, up to 30 days postoperatively
|
Length of hospital stay measured in days from surgery until hospital discharge.
|
From date of surgery until hospital discharge, up to 30 days postoperatively
|
|
Intensive Care Unit Stay
기간: From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
|
Duration of intensive care unit stay measured in days.
|
From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
|
|
Additional or Revision Spine Surgery
기간: Up to 24 months after surgery
|
Proportion of participants requiring additional spinal surgery or revision surgery during follow-up.
|
Up to 24 months after surgery
|
|
Perioperative Complications
기간: Perioperative/Periprocedural
|
Number and type of perioperative complications associated with the surgical procedure.
|
Perioperative/Periprocedural
|
|
Operative Parameters
기간: Perioperative/Periprocedural
|
Operative duration, intraoperative blood loss
|
Perioperative/Periprocedural
|
|
Dynamic Spondylolisthesis
기간: 24 month after surgery
|
Presence of dynamic spondylolisthesis defined as a translation of ≥3 mm on flexion-extension radiographs.Unit of Measure: Participants with dynamic spondylolisthesis.
|
24 month after surgery
|
|
Central Stenosis Severity Assessed by the Schizas Classification
기간: 24 months after surgery
|
Central canal stenosis at the adjacent segment assessed on MRI using the Schizas classification (Grades A-D).Unit of Measure: Grade (A-D; higher grades indicate more severe stenosis).
|
24 months after surgery
|
|
Foraminal Stenosis Severity Assessed by the Lee Classification
기간: 24 months after surgery.
|
Foraminal stenosis at the adjacent segment assessed on MRI using the Lee classification (Grades 1-4).Unit of Measure: Grade (1-4; higher grades indicate more severe foraminal stenosis).
|
24 months after surgery.
|
|
Implant Integrity
기간: 24 months after surgery.
|
Implant integrity assessed on radiographs, including evidence of implant loosening, breakage, or material dislocation.Unit of Measure: Participants with implant failure.
|
24 months after surgery.
|
|
Segmental Lordosis
기간: 24 months after surgery.
|
Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
|
24 months after surgery.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2030년 9월 30일
연구 완료 (추정된)
2031년 3월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 18일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STASS-Trial
- 574896382 (기타 보조금/기금 번호: Deutsche Forschungsgemeinschaft (DFG))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Individual participant data underlying the results reported in publications arising from this study, after de-identification, will be made available upon reasonable request to the corresponding investigator.
Supporting documents including the study protocol, statistical analysis plan, and data dictionary will also be made available.
IPD 공유 기간
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
IPD 공유 액세스 기준
De-identified individual participant data (IPD) underlying the results reported in publications arising from this study, as well as the study protocol, statistical analysis plan, and analytic code, will be made available to qualified researchers.
Access will be granted to investigators who provide a scientifically sound research proposal that is approved by the study steering committee. Requests must be submitted to the study sponsor and should specify the intended use of the data.
Data will be shared only after publication of the primary study results and following execution of an appropriate data-sharing agreement. Access will be provided through a secure electronic data transfer system in accordance with applicable data protection regulations.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .