Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
With the change of lifestyle and the aging of the population, the prevalence of Lumbar disc herniation (LDH) in my country is increasing year by year, and surgery is one of the main ways to treat LDH. Surgical robots have good application prospects in the surgical treatment of patients with lumbar degenerative diseases. Studies have shown that orthopedic robot-assisted surgery has less soft tissue damage, small surgical incisions, less bleeding, high safety, and quick postoperative recovery; it reduces the risk of spinal cord and blood vessel damage that may be caused during manual operations; does not require repeated fluoroscopy To determine the position of the nail, reduce the intraoperative radiation by more than 70%, and reduce the risk of patient infection.
The current clinical research on robotics technology mainly stays in the aspects of accuracy, effectiveness, and safety. If the technology is promoted in clinical applications, the support of health economics evaluation data is urgently needed. This study hopes to apply robot-assisted technology in LDH surgical treatment through observational research design, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, focus on health economics evaluation, and provide treatment options for patients and medical care in the health sector. The reasonable allocation of resources and the promotion and application of this technology provide data support.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：mingxing fan, MD,PHD
- 電話番号：+86-13683360600
- メール：van0208@163.com
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100000
- BeiJing JiShuiTan Hospital
-
コンタクト：
- Mingxing Fan, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnose lumbar degenerative diseases and lumbar fractures
- single-level lumbar pedicle screw internal fixation
- Sign informed consent
Exclusion Criteria:
- Multi-level lumbar pedicle screw internal fixation
- QCT diagnoses severe osteoporosis (BMD <60mg/cm3).
- Combined with abnormal coagulation function
- Combined with serious medical diseases
- Spinal cord injury, paraplegia
- The doctor or nurse believes that it is not appropriate to enroll patients (such as unable to cooperate in completing the study, unable to communicate effectively, severe mental anxiety, lower limb movement disorders, etc.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
free-hand
spine surgery without robot
|
|
|
robot-assisted
Robot-assisted open surgery
|
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
|
|
mi
Robot-assisted minimally invasive surgery
|
Tianji ROBOT--Orthopedic surgery robot led by Beijing Jishuitan Hospital
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
COST
時間枠：Up to 12 months
|
Perioperative cost
|
Up to 12 months
|
|
Visual Analogue Scale
時間枠：Up to 12 months
|
The basic method is to use a moving ruler with a length of about 10cm.
One side is marked with 10 scales.
The two ends are respectively "0" and "10" points.
A point of 0 means no pain, and a point of 10 means the most intolerable Severe pain.
|
Up to 12 months
|
|
Oswestry Disability Index
時間枠：Up to 12 months
|
The minimum score for each item is 0 points, and the highest score is 5 points.
The higher the score, the more severe the degree of dysfunction; the corresponding scores of the 10 items are accumulated.
Calculate the percentage of the highest score (50 points) of the 10 items, which is the Oswestry dysfunction index.
The higher the score, the more severe the patient's dysfunction.
|
Up to 12 months
|
|
modified Japanese orthopaedic association score
時間枠：Up to 12 months
|
Spinal function scoring method, including limb movement, sensory and bladder function evaluation, a total of 17 points.
The higher the score, the better the recovery of spinal cord function.
|
Up to 12 months
|
|
SF-36(Medical Outcomes Study Short-Form 36)
時間枠：Up to 12 months
|
Medical Outcomes Study S hort-Form 36.
There are 8 dimensions to evaluate health-related life quality (HRQOL), which are divided into two categories: physical health and physical health, namely physical function (PF), physical function (RP), physical pain (BP), General health (CH), vitality (VT), social function (SF), emotional function (RE), mental health (MH).
The score is between 0-100, a high score indicates a good health.
|
Up to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
operation time
時間枠：During surgery
|
operation time
|
During surgery
|
|
blood lose
時間枠：During surgery
|
blood lose
|
During surgery
|
|
Radiation dose
時間枠：During surgery
|
Radiation dose
|
During surgery
|
|
Complications
時間枠：immediately after the surgery, up to 12 weeks
|
Complications
|
immediately after the surgery, up to 12 weeks
|
|
Hospital stay
時間枠：days between in and out hospital
|
total hospital stay days
|
days between in and out hospital
|
|
Deviation of screw
時間枠：up to 12 months
|
The deviation between the actual position of screw and the preoperative designed position
|
up to 12 months
|
協力者と研究者
捜査官
- スタディチェア：tian wei, MD,PHD、BeiJing JiShuiTan Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
手術の臨床試験
-
Dong Yangわからない腹腔鏡補助下手術 | 切開を行わない全腹腔鏡手術（Natural Orifice Transluminal Endoscopic Surgery、NOSES）中国
Ti-robotの臨床試験
-
Zimmer BiometBiomet Spain Orthopaedics S.L.終了しました
-
Chinese University of Hong Kongまだ募集していません
-
IRCCS San Camillo, Venezia, ItalyFerRobotics Compliant Robot GmbH, Linz, Austria完了
-
Smith & Nephew, Inc.完了外反母趾の修理 | 内側または外側の不安定性の修復/再建 | アキレス腱の修復・再建 | 中足部の再建 | 中足骨靭帯/腱の修復/再建 | スカホルネート靭帯再建術 | 尺骨または橈側側副靭帯の再建 | 外側上顆炎の修復 | 上腕二頭筋腱の再付着オーストラリア
-
University of Roma La SapienzaMax-Planck Institute of Molecular Cell Biology and Genetics募集
-
Mannkind Corporation完了
-
University of Wisconsin, MadisonNational Institute on Drug Abuse (NIDA); University of Iowa; Iowa Department of Public Health完了