Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
2026年8月18日 更新者：Isto Biologics
Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF).
Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS).
The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin.
Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed.
A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.
調査の概要
状態
まだ募集していません
詳細な説明
Transforaminal lumbar interbody fusion (TLIF) is a widely used technique for degenerative lumbar spine pathology.
Prospective, randomized evidence on fusion outcomes, patient-reported outcomes, safety, and healthcare utilization for ProteiOS in TLIF is currently limited to retrospective data.
This study randomizes participants 2:1 to ProteiOS versus a within-category control (standard graft material, no ProteiOS), with central, blinded, independent radiographic review of CT and X-ray fusion outcomes.
The primary endpoint is CT-confirmed interbody fusion (BSF-3) at 12 months, tested for non-inferiority (margin = 5 percentage points, assumed fusion rates 95% ProteiOS vs. 89% control, 80% power, one-sided α = 0.025, Farrington-Manning likelihood score method).
Secondary endpoints include fusion at 6 and 24 months, X-ray-based interbody and posterolateral fusion assessment (Lenke classification for PLF), patient-reported outcomes at 3, 6, and 24 months, adverse events, and healthcare utilization
研究の種類
介入
入学 (推定)
280
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
- Age 18-75 years, skeletally mature at time of surgery
- Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon
- For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF
- Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation >3 mm)
- Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings
- Preoperative back pain ≥4 on a 0-10 VAS
- Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication
- Preoperative ODI score ≥30
- Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new/worsening motor weakness, bowel/bladder dysfunction, or cauda equina syndrome)
- Willing and able to comply with follow-up schedule and provide written informed consent
Exclusion Criteria:
- Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material
- BMI >40
- Prior lumbar spine fusion surgery at a level currently scheduled for surgery
- Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)
- Osteoporosis/osteopenia (≤2.5 SD below age-matched mean)
- Use of rhBMP-2 (Infuse) or other active biologics
- Active or systemic infection, malignancy, or severe metabolic bone disease
- Chronic steroid use (>10 days)
- Revision fusion at index levels
- Participation in another interventional clinical study within 30 days of consent
- Known pregnancy or intent to become pregnant during the study
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TLIF - ProteiOS (Treatment)
Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation.
If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag.
|
Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice
|
|
アクティブコンパレータ：TLIF - Control
5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS.
If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag.
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
|
実験的：ALIF - ProteiOS (Treatment)
Same ProteiOS-based mixture as TLIF treatment arm
|
Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice
|
|
アクティブコンパレータ：ALIF - Control
Same control graft composition as TLIF control arm
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
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 |
|---|---|---|
|
Rate of Fusion Success (via Computed Tomography (CT) analysis)
時間枠：12 months
|
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan.
BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
|
12 months
|
|
Patient Reported Outcome: Oswestry Disability Index (ODI)
時間枠：12 Months
|
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability), assessed at 12 months; mean scores compared between treatment and control arms.
|
12 Months
|
|
Patient Reported Outcome: Neurological
時間枠：12 Months
|
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
|
12 Months
|
|
Patient Reported Outcome: Visual Analog Scale (VAS)
時間枠：12 Months
|
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain), assessed at 12 months; mean scores compared between treatment and control arms.
|
12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fusion (via Computed Tomography (CT))
時間枠：6 and 24 months
|
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan.
BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
|
6 and 24 months
|
|
Fusion (x ray)
時間枠：3, 6, 12, 24 months
|
Percentage of participants achieving fusion by X-ray.
Interbody fusion (all participants): Brantigan-Steffee-Fraser (BSF) classification, Grade 1 (pseudarthrosis) to Grade 3 (solid fusion); success = Grade 3; higher grade = better.
|
3, 6, 12, 24 months
|
|
Adverse Events
時間枠：24 months
|
Nature (descriptive) and frequency (number) of procedure and biologic related Adverse Events and Serious Adverse Events
|
24 months
|
|
Patient Reported Outcome: Visual Analog Scale (VAS)
時間枠：3, 6, 24 Months
|
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain); mean scores compared between treatment and control arms.
|
3, 6, 24 Months
|
|
Patient Reported Outcome: Neurological
時間枠：3, 6, 24 Months
|
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
|
3, 6, 24 Months
|
|
Patient Reported Outcome: Oswestry Disability Index (ODI)
時間枠：3, 6, 24 Months
|
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability); mean scores compared between treatment and control arms.
|
3, 6, 24 Months
|
|
Healthcare utilization: Frequency of Hospital Visits
時間枠：Up to 24 months
|
Number of hospital visits per participant, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: Length of Hospital Stay
時間枠：Up to 24 months
|
Duration of hospital stay per participant, in days, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: ICU Time
時間枠：Up to 24 Months
|
Duration of ICU stay per participant, in days, up to 24 months.
|
Up to 24 Months
|
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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12月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2030年1月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月18日
最初の投稿 (実際)
2026年8月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月20日
QC基準を満たした最後の更新が送信されました
2026年8月18日
最終確認日
2026年8月1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。