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안정성 연구 (STABILITY)

2026년 11월 2일 업데이트: Spinal Simplicity LLC

안정성 연구: 요추의 퇴행성 질환에 대한 극간 유합 장치로 치료받은 환자의 기능적 운동 결과

This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Up to 150 subjects will be enrolled and treated at up to 20 study sites. Qualified subjects will be enrolled and treated with the Minuteman G5 Device. Subjects will be seen at 1-, 3-, 6- and 12-months following study treatment.

Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion.

After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.

연구 유형

중재적

등록 (추정된)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Georgia
      • Newnan, Georgia, 미국, 30265
        • 모병
        • Vista Clinical Research
        • 수석 연구원:
          • Sandeep Vaid, MD
        • 연락하다:
          • Debra Helton
    • Indiana
      • Indianapolis, Indiana, 미국, 46250
        • 모병
        • Comprehensive Pain & Spine Specialists
        • 수석 연구원:
          • Andrew Trobridge, MD
        • 연락하다:
          • Esther Owusu
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • 아직 모집하지 않음
        • University of Kansas Medical Center
        • 연락하다:
          • Manuel Clark
        • 수석 연구원:
          • Usman Latif, MD, MBA
        • 부수사관:
          • Dawood Sayed, MD
    • Louisiana
      • Slidell, Louisiana, 미국, 70458
        • 모병
        • Paradigm Health System
        • 연락하다:
        • 수석 연구원:
          • Neilson Tran, MD
    • Minnesota
      • Edina, Minnesota, 미국, 55435
        • 모병
        • Nura Precision Pain Management
        • 연락하다:
          • Ken Farmer
        • 수석 연구원:
          • R. Scott Stayner, MD
    • Oregon
      • Eugene, Oregon, 미국, 97404
        • 모병
        • Pacific Sports & Spine
        • 수석 연구원:
          • Gregory Moore, MD
        • 연락하다:
          • Katie Fabian
    • West Virginia
      • Charleston, West Virginia, 미국, 25301
        • 모병
        • Spine & Nerve Center of the Virginias
        • 수석 연구원:
          • Timothy Deer, MD
        • 연락하다:
          • Amy Young, RN-RC
        • 부수사관:
          • Christopher Kim, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria:

  1. Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
  2. Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided
  3. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
  4. Be 18 years of age or older at the time of enrollment
  5. Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
  6. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
  7. Be willing and able to comply with study-related requirements, procedures and visits
  8. Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
  9. Must disclose any unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the Investigator. Including being involved in an injury claim under current litigation or has a pending or approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.

Exclusion Criteria

A subject must NOT MEET ANY of the following exclusion criteria:

  1. Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
  2. Patient physically unable to perform the Gait and/or Balance tests.
  3. Current systemic infection or local infection increasing the risk of surgery
  4. History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
  5. Grade II-V spondylolisthesis
  6. Significant scoliosis with Cobb angle >10 degrees
  7. Unremitting back pain in a spinal flexion position
  8. Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
  9. Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
  10. Vertebral osteoporosis or history of vertebral fracture
  11. Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
  12. Malformation or dysplasia of spinous process
  13. Severe osteoporosis with T score <-2.5 SD

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Surgical Group

patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine
장치: Minuteman G5 Device

The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain (Overall, Back and Leg) using NRS/numeric rating scale
기간: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Oswestry Disability Index (ODI)
기간: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
PROMIS 29 2.0
기간: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

PROMIS-29 c2.0 is a set of standardized questions that measures 29 items across 7 domains of physical and mental health. PROMIS-29 profile assesses pain intensity using a single 0-10 numeric rating scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. And seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Each domain is scored on T-Score Scale ranging between 22.9- 81.6 with a mean of 50 and a standard deviation of 10.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Assessment of Motion using BioMech Lab testing equipment
기간: Baseline and 1-, 3- and 12-months post implantation.

A Primary Objective of this study is to collect real-world functional outcomes assessment of motion following treatment with the market-released Spinal Simplicity Minuteman G5 Device using BioMech Lab equipment to record gait and balance. The BioMech Lab motion analytics system will assess gait and balance via sensors placed before physical testing.
Baseline and 1-, 3- and 12-months post implantation.
Zurich Classification Questionnaire (ZCQ)
기간: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

The ZCQ Symptom Severity, Physical Function and Subject Satisfaction allows subjects to rate their symptoms, function or satisfaction on a scale based on their experience over the past week.

Symptom Severity domain evaluates the intensity of symptoms such as pain and numbness. It comprises seven items, each rated on a scale from 1 to 5. Overall symptom score ranges from 7-49; with higher scores indicating more severe symptoms.

Physical Function domain assesses the impact of symptoms on daily activities. It includes five items, scored on a 1 to 4 scale. Overall symptom score ranges from 5-20; where higher scores denote greater functional impairment.

Subject Satisfaction domain measures patient satisfaction with treatment outcomes. It consists of six items, each rated from 1 to 4, with higher scores reflecting greater dissatisfaction. Overall Satisfaction ranges from 6-24: where higher scores denote greater dissatisfaction.
Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

2차 결과 측정

결과 측정
측정값 설명
기간
Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan
기간: Collected at 12 months post implantation.

The secondary objective is to assess spinal fusion at 12 months post-operative using a Fusion Assessment Scale provided by Spinal Simplicity based on review of Lumbar CT Scan.
Collected at 12 months post implantation.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Spinal Simplicity LLC

수사관

  • 연구 의자: Tom Hedman, PhD, Spinal Simplicity

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 (실제)

2024년 5월 29일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2030년 12월 1일

연구 등록 날짜

최초 제출

2024년 3월 26일

QC 기준을 충족하는 최초 제출

2024년 4월 3일

처음 게시됨 (실제)

2024년 4월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PDPROJ-4-TP-001-23

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Patients will be deidentified with unique study ID. Any study will be anonymized.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

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. .

구독하다