- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07706439
Large-Scale Evaluation of a Clinical Decision Tree for the Management of Low-Energy Thoracic and Lumbar Vertebral Compression Fractures. (PALMTREE)
Studieoversikt
Status
Detaljert beskrivelse
Percutaneous vertebroplasty was first described in France in 1987 . Since its introduction, this minimally invasive technique has become widely accepted and is now a routine treatment for low-energy vertebral compression fractures (LEVCFs), also referred to as vertebral "crush" fractures. Clinical outcomes, including pain relief, analgesic consumption, and quality of life assessed through self-administered questionnaires, are commonly used to evaluate the effectiveness of the procedure.
Over the past 20 years, several randomized controlled trials (RCTs) have been conducted to assess the efficacy of vertebroplasty compared with non-surgical management (including bracing and placebo treatment). Two recent meta-analyses identified 13 RCTs published by January 2019 and 14 RCTs by July 2020, reaching different conclusions.
In 2019, Lou et al. concluded that percutaneous vertebroplasty was effective and safe only in patients with acute low-energy vertebral compression fractures associated with persistent and severe pain. In contrast, Lainez Ramos-Bossini et al. concluded in 2020 that vertebroplasty offered significant benefits compared with non-surgical treatment, including short-term pain relief and improved quality of life. However, these benefits appeared more limited when vertebroplasty was compared with placebo treatment.
The conclusion of the Cochrane review published by Buchbinder et al. in 2018 remains relevant today: "Based on high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty in the routine management of acute or subacute osteoporotic vertebral fractures." .
Furthermore, recent studies involving large patient cohorts have reported a significant rate of complications associated with percutaneous vertebroplasty. Among 1,932 patients, 166 (8.6%) experienced a complication, including 53 minor complications (2.7%) and 95 major complications (4.9%) . Patient selection appears to play a crucial role in the occurrence of complications, as suggested by Scheyerer et al. in a recent literature review .
The authors identified both non-modifiable and modifiable risk factors for perioperative and postoperative complications, including: age >90 years, male sex, low level of daily activity, partial or complete dependency, hospitalization, high American Society of Anesthesiologists (ASA) classification, Parkinson's disease, chronic obstructive pulmonary disease (COPD), arterial hypertension, renal failure, liver failure, coagulopathies, chronic steroid use, preoperative sepsis, and hypoalbuminemia (<3.5 g/dL) .
Simple preoperative markers, such as serum albumin levels, should therefore be considered when deciding whether vertebroplasty is appropriate for the treatment of low-energy vertebral compression fractures.
To improve the clarity and standardization of the management of patients presenting with low-energy vertebral compression fractures ("crush" fractures), we developed a clinical decision tree based on patient age, MRI findings, pain severity assessed using a Visual Analog Scale (VAS), and the extent of radiological deformity.
THE AIME OF THE STUDY IS : To evaluate the clinical and radiological healing outcomes of patients managed according to a clinical decision tree for one or more low-energy vertebral compression fractures (LEVCFs) at Grenoble Alpes University Hospital between January 1, 2022, and March 31, 2025.
Design of the study :Single-center prospective observational cohort study with no control group.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mehdi BOUDISSA, Pr
- Telefonnummer: 0476763275
- E-post: mboudissa@chu-grenoble.fr
Studer Kontakt Backup
- Navn: Sarah KASSAR-UNEISI, Pharm D
- Telefonnummer: 0476767524
- E-post: suneisi@chu-grenoble.fr
Studiesteder
-
-
-
La Tronche, Frankrike, 38700
- GRENOBLE ALPES UNIVERSITY HOSPITAL
-
Hovedetterforsker:
- Mehdi BOUDISSA, Pr
-
Ta kontakt med:
- Sarah PI KASSAR-UNEISI, Pharm D
- Telefonnummer: 0476767524
- E-post: suneisi@chu-grenoble.fr
-
Ta kontakt med:
- Mehdi PI BOUDISSA, Pr
- Telefonnummer: 0476763275
- E-post: mboudissa@chu-grenoble.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age > 50 years
- One or more low-energy vertebral compression fractures (LEVCFs) confirmed by MRI
- Fractures located between T7 and L5
- Compression fractures classified as A1.1, A1.2, or A1.3 according to the Magerl classification [15]
- Management in accordance with the clinical decision tree
- Vertebroplasty performed by an interventional radiologist, orthopedic surgeon, or neurosurgeon
- Vertebral augmentation performed by an orthopedic surgeon or neurosurgeon, with or without navigation assistance
- Conservative treatment consisting of a lumbar brace worn during daytime, with duration individualized according to the patient's needs, and physiotherapy initiated between 45 and 90 days after treatment, including core stabilization, stretching, and strengthening of the posterior muscle chain and abdominal muscles, based on active rehabilitation rather than manual therapy (no massage therapy).
Exclusion Criteria:
- Pregnant or breastfeeding women
- Individuals under administrative or judicial supervision
- Age < 50 years or > 90 years
- Pathological vertebral fracture
- Presence of other osteoporotic fractures during the study follow-up period (6 months)
- Non-compliance with the clinical decision tree
- Dementia or cognitive impairment preventing data collection at the final follow-up (telephone interview), assessed using the Mini-Cog test (score < 3 = exclusion)
- Refusal to participate during the telephone interview or inability to provide non-opposition (e.g., under legal guardianship)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the clinical and radiological healing outcomes of patients managed according to a clinical decision tree for one or more low-energy vertebral compression fractures (LEVCFs)
Tidsramme: 1 year
|
Radiological fracture healing, assessed on standard radiographs based on cortical continuity, disappearance of fracture lines, absence of progressive kyphosis, and absence of osteosynthesis hardware-related complications.
Fracture healing will be classified as complete, partial, or absent.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of radiological deformity.
Tidsramme: 1 year
|
Assessment of radiological deformity (vertebral kyphosis [VK], regional kyphosis [RK], and spinal canal narrowing) in patients managed according to the clinical decision tree
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
EVA -pain score
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
quality of life EQ5D 3 L
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
Mobility -Parker Mobility Score
|
1 year
|
|
Assessment of clinical outcomes
Tidsramme: 1 year
|
Analysis of risk factors for failure of conservative treatment
|
1 year
|
|
Assessment of vertebroplasty cement filling quality
Tidsramme: 1 year
|
(Garnier classification)
|
1 year
|
|
Assessment of fracture healing and associated factors
Tidsramme: 1 year
|
Evaluation of time to fracture healing, comparing conservative versus surgical treatment (measured in days; for surgical treatment, time is calculated from the date of surgery)
|
1 year
|
|
Assessment of fracture healing and associated factors
Tidsramme: 1 year
|
Assessment of the effect of calcium and vitamin D supplementation on fracture healing and the rate of refracture or new fractures.
|
1 year
|
|
Assessment of fracture healing and associated factors
Tidsramme: 1 year
|
Assessment of the effect of osteoporosis treatment on fracture healing and the rate of refracture or new fractures.
|
1 year
|
|
Assessment of complications
Tidsramme: 1 year
|
Perioperative and postoperative complications, including cement leakage, secondary lumbar spinal canal stenosis, intravertebral cleft (Kümmell disease), adjacent vertebral fractures, and pseudarthrosis (nonunion).
|
1 year
|
|
Assessment of treatment timelines
Tidsramme: 1 year
|
ime intervals (in days) between fracture occurrence and MRI, between MRI and surgical consultation, and between fracture occurrence and definitive treatment.
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 38RC26.0185
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .