Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease (MOBIDYN)
2026年5月5日 更新者：Cousin Biotech
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.
Patients will provide baseline socio-demographic and surgical data, complete patient-reported outcome measures (ODI, pain NRS, satisfaction), undergo imaging assessments (dynamic X-rays, EOS, MRI), and participate in safety evaluations including adverse event monitoring throughout follow-up.
調査の概要
研究の種類
介入
入学 (推定)
150
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patient, male or female, aged ≥ 18 years old
- Patient treated with BDyn device until end of December 2021, with between one and four fused level(s) maximum for the following indications: Degenerative intervertebral disc disease and/or articular facets confirmed by further examinations, Spinal canal stenosis, Degenerative spondylolisthesis grade 1, Segmental instability
- Patient who signed the informed consent form
- Patient affiliated with a social security scheme
Exclusion Criteria:
- Patients who are unable to provide informed consent due to cognitive impairment, language barrier, or any other condition that limits their ability to understand the nature, objectives, or potential risks of the study
- Patient that is pregnant or breastfeeding;
- Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;
- Patient who cannot comply with the protocol requirements based on the investigator's judgment
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patients treated with BDyn dynamic stabilization
All enrolled patients undergo lumbar dynamic stabilization using the BDyn device.
Clinical, radiological, and patient-reported outcomes are collected during long-term follow-up.
|
BDyn is intended for spine surgery with a posterio approach.
The sterile spinal dynamic posterior stabilization devices BDyn is intended to restore the stabilization of the spine segment from T10 to S1 by preserving the anatomical lordosis and the deadening of the intervertebral joint.
他の名前：
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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 |
|---|---|---|
|
Reoperation rate at the upper adjacent segment
時間枠：Through study completion, an average of 10 year
|
Cumulative reoperation rate at the upper adjacent segment will be defined as the occurrence of reoperation at this level over long-term postoperative follow-up (≥4 years)
|
Through study completion, an average of 10 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reoperation rate at the instrumented segment
時間枠：Through study completion, an average of 10 year
|
The aim is to estimate the cumulative reoperation rate at the instrumented segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe upper adjacent segment integrity
時間枠：Through study completion, an average of 10 year
|
To evaluate the upper adjacent segment integrity in patients treated with BDyn dynamic stabilization for lumbar degenerative disc disease over long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
時間枠：Through study completion, an average of 10 year
|
To describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe disc height of the stabilized segment, the upper and lower adjacent segment
時間枠：Through study completion, an average of 10 year
|
Intervertebral disc height measured in millimeters on MRI at the stabilized segment and adjacent segments (upper and lower), assessed at baseline and during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe sagittal balance
時間枠：Through study completion, an average of 10 year
|
To measure the angle of sagittal balance (the innate neutral standing position with C7 positioned over S1) in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment
時間枠：Through study completion, an average of 10 year
|
Intervertebral disc degeneration assessed using the Pfirrmann grading system (grades I-V) on MRI for the stabilized segment and adjacent segments (upper and lower), evaluated at baseline and during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe disability
時間枠：Through study completion, an average of 10 year
|
Disability assessed using the Oswestry Disability Index (ODI), reported as a total score ranging from 0 to 100, evaluated at baseline and during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe back pain
時間枠：Through study completion, an average of 10 year
|
Change from baseline in back pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe leg pain
時間枠：Through study completion, an average of 10 year
|
Change from baseline in leg pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe satisfaction
時間枠：Through study completion, an average of 10 year
|
Patient satisfaction measured using a patient-reported outcome questionnaire, reported as a total score (range to be specified), assessed during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
|
Describe perioperative outcomes
時間枠：Through study completion, an average of 10 year
|
Number of participants with perioperative complications within 30 days after surgery
|
Through study completion, an average of 10 year
|
|
Describe clinical safety
時間枠：Through study completion, an average of 10 year
|
Number of participants requiring reoperation at the treated or adjacent segments during long-term postoperative follow-up
|
Through study completion, an average of 10 year
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年4月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年5月1日
詳しくは
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