Proximal Junctional KyphosisTRANSITIONNCT07618897
Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity
A study testing Tether strategy and Reference in people with Proximal Junctional Kyphosis, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Junctional Kyphosis
- What is being tested?
- Tether strategy and Reference
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 6 sitesFrance
- Study dates
- 22 Oct 2026to 22 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CHU Bordeaux
Bordeaux, 33000
Benjamin BOUYER, MD, PU-PH, +33 5 57 82 26 26, b.bouyer@chu-bordeaux.fr
Benjamin BOUYER, MD, PU-PH
CHU Limoges
Limoges, 87000
François CAIRE, MD, PU-PH, +33 5 55 05 65 21, francois.caire@chu-limoges.fr
François CAIRE, MD, PU-PH
Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Service de Neurochirurgie - Chirurgie du Rachis et de la Moëlle Epinière
Lyon, 69394
Cédric BARREY, Ph, +33 4 72 11 80 67, cedric.barrey@chu-lyon.fr
Julien BERTHILLER, +33 4 27 85 63 01, julien.berthiller@chu-lyon.fr
AP-HM CHU La Timone
Marseille, 13005
Stéphane FUENTES, MD, PU-PH, +33 4 91 38 55 45, Stephane.FUENTES@ap-hm.fr
Stéphane FUENTES, MD, PU-PH
AP-HP Hopital Européen Georges Pompidou
Paris, 75015
Emmanuelle FERRERO, MD, PU-PH, +33 1 56 09 57 00, emmanuelle.ferrero@aphp.fr
Emmanuelle FERRERO, MD, PU-PH
CHRU Tours
Tours, 37044
Aymeric AMELOT, MD, PU-PH, +33 2 47 47 37 16, a.amelot@chu-tours.fr
Aymeric AMELOT, MD, PU-PH
About this study
Official title: 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.
Read more
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.
- Conditions
- Proximal Junctional Kyphosis
- Being tested
- Tether strategy, Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tether strategyDevice
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.
ReferenceProcedure or surgery
Patient will undergo the spine surgery as the standard of care, using only standard posterior rigid instrumentation (i.e. screws and metallic rods).
| Study group | Role | What they receive |
|---|---|---|
| Patient instrumented with a tether | Experimental | Sub-laminar and/or interspinous tethers Receives: Device: Tether strategy |
| Reference strategy | Active comparator | Standard surgery Receives: Procedure: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-laminar and/or interspinous tethers efficacy to prevent PJK
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
Measured: From enrollment to 24 months post-surgery
Secondary outcomes (7)
Sub-laminar and/or interspinous tethers efficacy to prevent PJF
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
Measured: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent surgery revision
Percentage of patients with an indication of revision surgery
Measured: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent the level of disabilty
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.
Measured: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent pain
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.
Measured: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to enhance quality of life
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.
Measured: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent post-operative complications
The number of peri- and post-operative complications including mechanical complication due to the device, infections, neurological and general complications.
Measured: 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
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.
Measured: From enrollment to 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start22 Oct 2026 (estimated)
- Primary completion22 Jun 2030 (estimated)
- Study completion22 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Junctional KyphosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric BARREY, Ph, Principal investigator, Hospices Civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618897
- Sponsor's protocol ID
- 69HCL24_0720
- Other IDs
- 2026-A00732-49
- Acronym
- TRANSITION
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07618897
- Acronym / sponsor ID
- TRANSITION / 69HCL24_0720
- Conditions
- Proximal Junctional Kyphosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 22 Jun 2030 (estimated)
- Study completion
- 22 Jun 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient instrumented with a tether | Experimental | Device: Tether strategySub-laminar and/or interspinous tethers |
| Reference strategy | Active comparator | Procedure: ReferenceStandard surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tether strategyDuring 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. | Device | Patient instrumented with a tether |
| ReferencePatient will undergo the spine surgery as the standard of care, using only standard posterior rigid instrumentation (i.e. screws and metallic rods). | Procedure or surgery | Reference strategy |
Primary outcome
Sub-laminar and/or interspinous tethers efficacy to prevent PJK
Time frame: 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
7 secondary outcomes
Sub-laminar and/or interspinous tethers efficacy to prevent PJF
Time frame: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent surgery revision
Time frame: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent the level of disabilty
Time frame: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent pain
Time frame: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to enhance quality of life
Time frame: From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent post-operative complications
Time frame: 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
Time frame: From enrollment to 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Proximal Junctional Kyphosis
Not yet recruitingObservational study
Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
Thoracolumbar Spinal Fusion
RecruitingObservational study
Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
Adult Spinal Deformity, Scoliosis
RecruitingPhase 4
Post-Operative Thoracolumosacral Orthosis for PJK
Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cédric BARREY, Ph principal investigator
Hospices Civiles de Lyon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tether strategy and Reference in people with Proximal Junctional Kyphosis, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cédric BARREY, Ph (+33 4 72 11 80 67, cedric.barrey@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-laminar and/or interspinous tethers efficacy to prevent PJK (time frame: From enrollment to 24 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.