도관 대 엿보기 케이지
직접 측면 뇌 융합 (DLIF)을 겪고있는 환자의 도관 대 엿보기 케이지 : 무작위, 전향 적 시험
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. This will be a randomized, prospective, open-label clinical trial. By examining these two groups, the PI hope to determine whether PEEK cages with rhBMP-2 and CONDUIT cages are equally effective for DLIF procedures. The findings from this study will help us optimize the surgical approach for future patients undergoing DLIF.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Direct lateral interbody fusion (DLIF) is a powerful surgical tool in a spine surgeon's armamentarium to address lumbar spine pathology minimally invasively. It has been widely adopted amongst spine surgeons to gain access to the lumbar disc through a small incision on a patient's flank. Through a retroperitoneal approach, the surgeon can perform discectomy, prep end plates, and insert an interbody cage with a much longer (lateral-medial) and wider (anterior-posterior) footprint than posterior lumbar interbody fusion (PLIF). Using either transpsoas or anterior-to-psoas (ATP) technique, the surgeons are now able to address lumbar spine pathologies affecting L2 to S1 minimally invasively. Both approaches are acceptable and widely adopted amongst spine surgeons. There are many commercially available FDA-approved DLIF cages in market for spine surgeons to use. The cages made of polyetheretherketone (PEEK) and titanium are most commonly used. Many surgeons who use PEEK cages in DLIF supplement the construct with recombinant human bone morphogenic protein-2 (rhBMP-2) to achieve fusion. PEEK has an inert and hydrophobic property which does not induce osteogenesis. In-vitro studies demonstrate absence of bone formation through PEEK. By adding rhBMP-2, it may induce robust osteoinduction around PEEK, achieving fusion across disk space over time. On the other hand, porous titanium has all three properties: osteoconductivity, osteoinductivity, and osseointegration. This may create a more favorable environment for fusion, which obviates the need for rhBMP-2 supplementation. Both types of cages are approved for the study's indications and are routinely used in DLIF at Penn. The surgical staff is qualified to implant both devices.
Aside from the type of cage used, subjects' DLIF procedures will not be altered for the purposes of the study. There are no known differences in the risks and benefits of the two cages being studied. Cage choice in routine care is based on each individual surgeon's standard-of-care preference. As such, there is a possibility of the patient getting either of these cages placed, should they choose to not participate in the study.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Pennsylvania Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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• Patients with one to two consecutive level lumbar degenerative disease from L2to S1, including Grade 1 (<25%) Spondylolisthesis
- Patients undergoing direct lateral interbody fusion (transpsoas or anterior-to-psoas approach) for lumbar disease
- Skeletally mature patients, aged 18 and older
- Patients able to fully comply with the clinical protocol and adhere to the follow-up schedule and protocol requirements
- Patients able to understand and sign the study-specific, IRB approved informed consent form
Exclusion Criteria:
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• Spondylolisthesis greater than Grade 1
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Traumatic lumbar disease
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Spinal Deformity
- Coronal Cobb angle greater than 40 degrees
- Severe sagittal imbalance
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Existing fusion construct longer than 2 consecutive levels
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Active infection - systemic or local
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Tumor diagnosis
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Untreated osteoporosis, defined as T Spine < -2.5 on DEXA scan
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Active smoking habit
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Current incarceration
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Pregnancy
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Involvement in an active spinal litigation
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: Conduit
Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. |
Comparison between cages to determine the effectiveness and cost related to the study procedures. |
|
다른: PEEK + rh-BMP-2 cage
Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. |
Comparison between cages to determine the effectiveness and cost related to the study procedures. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical outcomes
기간: 24 months
|
Difference in fusion rates for patients who get the PEEK + rh-BMP-2 cage and those who get the CONDUIT cage. |
24 months
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ODI scores
기간: 24 months
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The ODI is comprised of ten items with associated statements for the patient to select which reflect the patient's ability to manage their everyday life while dealing with their pain. Each of the ten items in the ODI has six statements from which patients are requested to select one. This allows scoring from 0-5 for each item. A maximum score of 50 is possible. The score obtained by individual patients can be multiplied by 2, and this will provide a percentage score |
24 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cost
기간: 24 months
|
Costs associated with the PEEK + rh-BMP-2 and CONDUIT cages will be assessed. |
24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 844964
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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