Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Vertebral Compression Fractures

NCT02489825 | Terminated Phase 4

• 2 other identifiers: 008/1313-01-F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.

Conditions

Osteoporosis; Vertebral Fracture

Keywords

randomized controlled trial; vertebral fracture; osteoporosis; vertebroplasty; augmentation

Outcome Measures

Primary Outcomes (1)

• Number of new operations within 6 months after vertebroplasty due to adjacent or distant segment fracture.

  Measured by interview, clinical \& radiographic assessment

  6 months after index surgery

Secondary Outcomes (2)

• Disease specific quality of life (COMI back form)

  6 months after index surgery

• General quality of life

  6 months after index surgery

Study Arms (2)

Augmentation vertebroplasty

OTHER

Single level fracture fixation with vertebroplasty

Procedure: Augmentation vertebroplasty

Augmentation and prophylactic vertebroplasty

OTHER

Triple level augmentation with VP fixation of the fracture and additional prophylactic vertebroplasty in both the adjacent levels

Procedure: Augmentation and prophylactic vertebroplasty

Interventions

Augmentation vertebroplasty PROCEDURE

Cement augmentation of fractured vertebral body

Augmentation vertebroplasty

Augmentation and prophylactic vertebroplasty PROCEDURE

Cement augmentation of fractured vertebral body and prophylactic augmentation of both adjacent vertebral bodies

Augmentation and prophylactic vertebroplasty

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years
• Written informed consent
• Single level acute (\< 6 weeks) vertebral compression fracture
• Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis
• Patients with Association for the study of Osteosynthesis (AO) type A1.x fractures and A3.1 fractures may be included in the study
• Target Vertebral Compression Fracture (VCF) is between T10 and L4
• Target VCF to be treated shows either: height change - an acute (\< 6 weeks) change in VB height (\>15% height loss) with height loss at the anterior or middle portion of the VB consistent with a worsening of 1 or more grades acc to Genant
• OR positive MRI or bone scan - VB shows hyperintense signal on MRI-T2 or STIR sequence
• OR target VB is positive on radionuclide bone scan
• Back pain correlating with the location of the VCF
• Treatment of target and adjacent VCFs is technically feasible by and clinically appropriate for vertebroplasty
• No previous VCFs
• No major surgery of the spine planned for at least 6 months following enrollment
• Pre-treatment back pain by numerical rating scale (NRS) score \> 4 (0-10 scale)
• Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

You may not qualify if:

• VB morphology or configuration is such that vertebroplasty is not technically feasible for the targeted and adjacent VCFs
• Fracture due to high-energy trauma
• Suspected OR proven cancer inside index vertebral body
• Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
• Any painful VCF with fracture age \> 6 weeks
• Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index or adjacent VCF
• Any objective evidence of neurologic compromise at baseline.
• Previous balloon kyphoplasty, VBS or vertebroplasty for any VCF
• Significant clinical comorbidity that may potentially interfere with follow-up (e.g., dementia, severe comorbid illness)
• Patients requiring the use of high-dose steroid (\>= 100mg prednisone or 20 mg dexamethasone per day), IV pain medication, or nerve block to control chronic back pain unrelated to index VCF
• Spinal cord compression or canal compromise requiring decompression
• Patients with osteoblastic tumors at the site of the index VCF
• MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
• Spinal instability as indicated by neurologic deficit, kyphosis \>30°, compression \>50%, translation \>4 mm, interspinous-process widening.
• Pre-existing conditions contrary to vertebroplasty, such as: irreversible coagulopathy or bleeding disorder

Sponsors & Collaborators

• University of Bern: lead
• Sonnenhof Hospital, Bern: collaborator

Study Sites (1)

Sonnenhof hospital, dept. of spinal surgery

Bern, 3006, Switzerland

Location

Related Publications (1)

• Diel P, Freiburghaus L, Roder C, Benneker LM, Popp A, Perler G, Heini PF. Safety, effectiveness and predictors for early reoperation in therapeutic and prophylactic vertebroplasty: short-term results of a prospective case series of patients with osteoporotic vertebral fractures. Eur Spine J. 2012 Aug;21 Suppl 6(Suppl 6):S792-9. doi: 10.1007/s00586-011-1989-x. Epub 2011 Aug 30.

  PMID: 21877131 RESULT

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Paul Heini, MD, professor, head of dept.

  Sonnenhof Hospital, Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 3, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CH (1)