공급품의 내구성 긴 분절 후방 기구를 이용한 척추 유합술을 위한 막대 구조-보조 막대 기술
장분절 후방 기구를 이용한 척추 유합술을 위한 보충 막대 구조물 - 보충 막대 기술(SMART)의 내구성: 이중 막대 구조물을 사용한 다기관 후향적 비교 연구
This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.
연구 개요
상세 설명
This multicenter retrospective comparative cohort study will enroll 1244 patients, who underwent primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. By comparing two groups of patients, ie, patients treated with supplementary rod constructs vs dual-rod constructs, in the setting of long-segment posterior instrumented spinal fusion, this study aims to provide quality evidence regarding the benefits of supplementary rod constructs in reducing the risk of RFs and other mechanical complications. This study shall provide the first long-term clinical evidence on clinical outcome and benefit of supplementary rod constructs.
All participating surgeons will be asked to identify a time point, denoted as X, when they started using predominantly either supplementary rod constructs or dual-rod constructs for long-segment posterior TL instrumented spinal fusion. This time point X must be on or before December 31, 2020 (the last eligible date for the index surgery). Participating surgeons will be instructed to select the time point X to be as early within the collection window as feasible to maximize the available FU period.
Once the time point X is identified for a participating surgeon, medical records of patients treated by this surgeon will be reviewed to identify consecutive eligible patients with the index surgery done between the time point X and December 31, 2020, inclusive. In the case that an eligible patient had undergone several surgeries during this period, the first primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct or a dual-rod construct is defined as the index surgery.
Patients will then be grouped based on the rod constructs into either the supplementary rod construct group or dual-rod construct group.
The study has two FU periods:
- The first FU period is the first 2 years after the index surgery. The primary analysis will be done using data from the first 2 years of FU.
- The second FU period ends on December March 31, 20232024. The duration of this FU therefore ranges from 3 years and 3 months to 10 years and 3 months.
The primary study endpoint is the occurrence of the first RF within 2 years after the index surgery.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Viola Grünenfelder
- 전화번호: +41 79 696 33 97
- 이메일: viola.gruenenfelder@aofoundation.org
연구 연락처 백업
- 이름: Alix Frischknecht
- 전화번호: +41 79 606 41 48
- 이메일: alix.frischknecht@aofoundation.org
연구 장소
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California
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Redwood City, California, 미국, 94588
- 모병
- Stanford Spine Clinic
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연락하다:
- Serena Hu, MD
- 이메일: shu3@stanford.edu
-
Sacramento, California, 미국, 95819
- 모병
- University of California
-
연락하다:
- Yashar Javidan
- 이메일: yjavidan@ucdavis.edu
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San Francisco, California, 미국, 94144
- 종료됨
- UCSF Spine Center
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Maryland
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Baltimore, Maryland, 미국, 21287
- 모병
- John Hopkis Hospital
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연락하다:
- Khaled Kebaish
-
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Minnesota
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Minneapolis, Minnesota, 미국, 55454
- 모병
- University of Minnesota Medical Center
-
연락하다:
- David Polly, MD
- 이메일: pollydw@umn.edu
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University in St. Louis, School of Medicine
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연락하다:
- Brian Neuman
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St Louis, Missouri, 미국, 63310
- 완전한
- Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
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New York
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New York, New York, 미국, 10032
- 모병
- Columbia University / NYP Och Spine Hospital
-
연락하다:
- Zeeshan Sardar
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Virginia
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Charlottesville, Virginia, 미국, 22908
- 모병
- University of Virginia
-
연락하다:
- Justin S Smith, MD, PhD
- 전화번호: 434-243-6339
- 이메일: jss7f@virginia.edu
-
연락하다:
- Judith G Beenhakker
- 이메일: JGB3P@uvahealth.org
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Barcelona, 스페인, 08035
- 모병
- Hospital Vall d´Hebron
-
연락하다:
- Ferran Pellisé, MD
- 이메일: 24361fpu@comb.es
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Kolkata, 인도
- 모병
- Kothari Medical Centre
-
연락하다:
- Saumayajit Basu, MD
- 이메일: saumyajitbasu@hotmail.com
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Hamamatsu, 일본, 431-3192
- 완전한
- Hamamatsu University School of Medicine
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Tokyo, 일본, 113-8654
- 모병
- University of Tokyo
-
연락하다:
- So Kato, Prof
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Hong Kong, 중국
- 완전한
- Duchess of Kent Children's Hospital
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Calgary, 캐나다, T2N 2T9
- 모병
- University of Calgary Spine
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연락하다:
- Ganesh Swamy
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Toronto, 캐나다, M5T 2S8
- 모병
- University of Toronto
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연락하다:
- Stephen Lewis
-
연락하다:
- Christopher Nielsen
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Istanbul, 터키 (Türkiye)
- 모병
- Acibadem Maslak Hospital
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연락하다:
- Caglar Yilgor, MD
- 이메일: caglaryilgor@gmail.com
-
연락하다:
- Ahmet Alanay
- 이메일: aalanay@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion
설명
Inclusion Criteria:
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Age 45 years and older.
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Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).
- Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.
- Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.
- The index surgery can be a primary surgery or a revision surgery.
- The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure.
-
If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place.
o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum/ilium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum/ilium.
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The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.
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Minimum 3 months of FU after the index surgery.
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Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis.
Exclusion Criteria:
- Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).
- Spinal fusion performed for tumor.
- Spinal fusion performed for infection.
- Patients with Parkinson's Disease.
- Patients with neuromuscular disorders.
- Patients with spine malignancies requiring chemo- or radiation therapy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct. |
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs. |
|
primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct. |
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rod fracture (RF)
기간: 2 years
|
Incidence of rod fracture(s) |
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to rod fracture
기간: 2 years
|
Time to the first rod fracture after index surgery |
2 years
|
|
Time to rod fracture
기간: 10 years and 3 months
|
Time to the first rod fracture after index surgery |
10 years and 3 months
|
|
Configurations of supplementary rod constructs
기간: Baseline
|
Descriptions of configurations of supplementary rod constructs |
Baseline
|
|
Treatment for rod fracture
기간: 10 years and 3 months
|
Descriptions of different treatment strategies for rod fractures |
10 years and 3 months
|
|
Recurrent RFs
기간: 10 years and 3 months
|
Incidence of recurrent rod fractures |
10 years and 3 months
|
|
Other mechanical failures
기간: 10 years and 3 months
|
Other mechanical failures other than rod fractures |
10 years and 3 months
|
|
Surgical complications
기간: 10 years and 3 months
|
Selective surgical complications |
10 years and 3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Justin S Smith, MD, PhD, Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SMART
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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