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Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity (TRANSITION)

2026년 5월 28일 업데이트: Hospices Civils de Lyon

Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity - Randomized Multicentric Single Blind Controlled Trial

PJK (proximal junctional kyphosis) at the upper end of spinal fusions after surgical correction of adult spinal deformity is not uncommon. Two-thirds of cases are observed within the first 3 months after surgery and 80% within the first 18 months. PJK is consequently a common problem after surgery for adult spinal deformity, representing one of the most frequent complications following this kind of procedure. Although the first-line treatment of this event is conservative, surgery may be necessary in around 30-40% of cases. Revision surgery generally consists of extending the posterior spinal instrumentation.

Prophylactic vertebroplasty has been proposed to reduce the risk of PJK and PJF, with promising results but with the limitation of reinforcing only the bony structures, with no action on the soft tissues. In this context, some authors have reported that the use of tethers, creating a transitional zone at the upper end of the construct between the fused and the non-instrumented spine, could reduce the occurrence of this complication (PJK). One of the hypotheses is that the use of a topping-off system results in a transitional zone reducing stresses at the junctional spine and may reduce the occurrence of both PJK and the need for reoperation.

Compared with other topping-off systems, such as hooks, the surface of contact provided by the bands on the posterior arches is much greater and the primary stability much better. In addition, the risk of malposition is extremely low.

The aim of this study is therefore to compare the occurrence of PJK and PJF in patients for whom tethers were implanted at the upper end of the instrumentation versus patients for whom no tether system was used.

In a retrospective study conducted in the neurosurgery department of the HCL on 38 patients undergoing multilevel spine instrumentation with junctional tethers, PJK occurred in 8 of them (21%) after 24 months of follow-up.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

128

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

  • 프랑스
      • Lyon, 프랑스, 69394
        • Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Service de Neurochirurgie - Chirurgie du Rachis et de la Moëlle Epinière
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Cédric BARREY, Ph

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Patient men and women older than 18
  • Patient indicated spinal posterior fusion and instrumentation with the upper end (UIV with screws) between T9 and L2 and the lower end between L5 and iliac
  • Constructs ≥4 levels (i.e., ≥4 discs included)
  • Patient able to signed a consent form
  • Patient able to fill a self-administered questionnaire
  • Patient affiliated to health care insurance (social security in France

Exclusion Criteria:

  • Allergy to metal
  • Cimentoplasty at the junctional zone (UIV, UIV+1 and/or UIV+2)
  • Bone metabolism disorders that potentially compromise the mechanical support expected from this type of implant.
  • Morbid obesity (BMI > 40)
  • Patients with infection (in particularly osteomyelitis)
  • Cancer of lesss than 5 years or currently treated
  • Acute trauma
  • Immunodepression
  • Parkinson
  • Chronic inflammatory disease
  • Severe psychological disorders
  • Pregnancy or women breastfeeding
  • Inadequate tissue coverage of implant site,
  • Interference with other critical anatomical structures.
  • Patient not being able to understand the objectives of the study or refusing to comply with postoperative instructions
  • Patient participating in an ongoing study that may interfere with this study
  • Patient under legal protection

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Patient instrumented with a tether
Sub-laminar and/or interspinous tethers
장치: Tether strategy
During spine surgery sub-laminar or interspinous bands are utilized in combination with standard posterior rigid instrumentation (i.e. screws and metallic rods). They are typically implanted at the upper vertebral level, above the cranial screws, and then connected to the rods. Their implantation is based on standard surgical techniques for spine surgeons.
활성 비교기: Reference strategy
Standard surgery
절차: Reference
Patient will undergo the spine surgery as the standard of care, using only standard posterior rigid instrumentation (i.e. screws and metallic rods).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sub-laminar and/or interspinous tethers efficacy to prevent PJK
기간: From enrollment to 24 months post-surgery

Percentage of patients with PJK during the first post-operative 24 months with PJK defined as :

  • a proximal junctional sagittal Cobb angle (PJA) between the lower endplate of uppermost instrumented vertebra (UIV) with screws and the upper endplate of 2 supra-adjacent vertebra ≥15
  • a 15° delta between 24months post operative PJA and preoperative PJA These 2 parameters will be assessed by an independent committee using radiographic images preop and 24 months postop
From enrollment to 24 months post-surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Sub-laminar and/or interspinous tethers efficacy to prevent PJF
기간: From enrollment to 24 months post-surgery
Comparison between the 2 randomized groups with or without tethers at 24 months: Percentage of patients with PJF, defined as a progressive process in the spectrum of PJK with structural failures such as vertebral body fracture and/or posterior ligament complex, and vertebral subluxation
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent surgery revision
기간: From enrollment to 24 months post-surgery
Percentage of patients with an indication of revision surgery
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent the level of disabilty
기간: From enrollment to 24 months post-surgery
Disability assed with Oswestry Disability Index questionnaire. It is composed of questions on the following items : pain intensity, personal care (washing, dressing), lifting objects, moving around, sitting or standing, sleeping, sex life, social life, and travel/transportation. Each items is scored from 0 to 5, 0 being absence of disability and 5 the most severe disability. The final score range from 0 to 50 and there is 6 level of disability according to final score categories: 0-4 no disability, 5-14 light disability, 15-24 moderate disability, 25-34 severe disability and 35-50 complete disability.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent pain
기간: From enrollment to 24 months post-surgery
Evolution of radicular and lumbar Pain assessed with a Visual Analogic Scale rated from 0 to 10, 0 being the absence of pain and 10 the worst pain ever experienced.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to enhance quality of life
기간: From enrollment to 24 months post-surgery
Evolution of the mean Quality-of-Life score will be assessed using the EQ-5D-5L questionnaire. The EQ-5D-5L, developed by the EuroQol Group to improve sensitivity and reduce ceiling effects, includes two components: the descriptive system and the visual analogue scale (EQ VAS). The descriptive system covers five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on five levels from no problems to extreme problems, generating a 5-digit health state code. The EQ VAS records the patient's self-rated health on a vertical scale ranging from the best to the worst imaginable health, providing a quantitative measure based on the patient's own judgement.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent post-operative complications
기간: From enrollment to 24 months post-surgery
The number of peri- and post-operative complications including mechanical complication due to the device, infections, neurological and general complications.
From enrollment to 24 months post-surgery
Assess the efficiency of implanting tethers at the upper part of the construct in patient with an indication for spinal posterior fusion performing cost-utility and cost-effectiveness analyses
기간: From enrollment to 24 months post-surgery
Incremental cost-utility and cost-effectiveness ratios of implanting tethers at the upper part of the construct (tethers group) compare to the standard procedure without tethers at 24 months post-surgery.
From enrollment to 24 months post-surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospices Civils de Lyon

수사관

  • 수석 연구원: Cédric BARREY, Ph, Hospices Civiles de Lyon

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)

2026년 6월 22일

기본 완료 (추정된)

2030년 6월 22일

연구 완료 (추정된)

2030년 6월 22일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 69HCL24_0720
  • 2026-A00732-49 (기타 식별자: ID-RCB)

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. .

근위 접합부 후만증에 대한 임상 시험

Tether strategy에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Czech Republic

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약물 개입

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스폰서 / 협력자

위치

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