Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
2026년 8월 18일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
중재적
등록 (추정된)
등록
280
단계
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
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
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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
|
|
활성 비교기: 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
|
|
실험적: 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
|
|
활성 비교기: ALIF - Control
Same control graft composition as TLIF control arm
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Fusion Success (via Computed Tomography (CT) analysis)
기간: 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)
기간: 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
기간: 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)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fusion (via Computed Tomography (CT))
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: Up to 24 months
|
Number of hospital visits per participant, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: Length of Hospital Stay
기간: Up to 24 months
|
Duration of hospital stay per participant, in days, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: ICU Time
기간: Up to 24 Months
|
Duration of ICU stay per participant, in days, up to 24 months.
|
Up to 24 Months
|
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)
연구 시작
2026년 12월 1일
기본 완료 (추정된)
기본 완료
2029년 12월 1일
연구 완료 (추정된)
연구 완료
2030년 1월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 11일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 18일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 18일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CS-07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .