Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.

NCT00748631 | Terminated

• 1 other identifier: P050323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications. This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure. Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient. The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

Conditions

Vertebral Fracture; Multiple Myeloma; Osteolytic Metastases

Keywords

Vertebral fracture; Vertebral compression fracture; Multiple Myeloma Bone marrow diseases; Vertebral metastases; Balloon Kyphoplasty

Outcome Measures

Primary Outcomes (1)

• Percentage of patients having a residual pain of ≤ 35mm on a VAS scale or a 50 % decrease in daily morphine dose at day 15 after Balloon Kyphoplasty compared to day 0 (day of procedure).

  day 15

Secondary Outcomes (12)

• 1° Clinical Outcomes:· Pain evaluation using a visual analogic scale

  D-8-D-1, D2 to D5, d15, D90, D180; D360

• quality of life evaluation (SF 12).

  D-8 to D-1, D2 to D5, D15, D90, D180; D360

• Assessment of the pain due to the compression fracture using a VAS scale in the same position as at the inclusion visit (standing or lying down),

  D-8 to D-1, D2 to D5, D15, D90, D180; D360

• Assessment of the patient global satisfaction score using a LICKERT Scale,

  D-8 to D-1, D2 to D5, D15, D90, D180; D360

• Percentage of patients who estimate than the pain due to the compression has decreased by more than 50% after the procedure,

  day 15

Study Arms (1)

1

EXPERIMENTAL

balloon Kyphoplasty

Device: balloon kyphoplasty

Interventions

balloon kyphoplasty DEVICE

A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach.Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity.The balloons are then deflated and removed. The Bone Filler Device is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula.

1

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 years or older
• to 3 vertebral compression fracture(s), between T5-L5, responding to the following criteria:
• at least 15% loss of vertebral body height (anterior, median or posterior);
• malignant origin (bone metastases, multiple myeloma, hemopathy) assessed by imaging, including an MRI and a CT-SCAN of less than 4 weeks.
• Pain or painful deterioration less than 3 months old, related to one or more vertebral fractures with a VAS higher than 50/100 mm when changing position, or higher than 40/100 mm if associated with morphine ≥ 30 mg/day ;
• The pain related to the fractured vertebrae is the more prevalent
• More than 3 months life expectancy.
• Blood Platelets rate more than or equal to 50 000/mm3 within the week before balloon kyphoplasty procedure (after a correct blood transfusion).
• Patient must have signed a consent form.
• Patient affiliated to social security

You may not qualify if:

• Patient younger than 18
• Impossibility to perform Balloon Kyphoplasty:
• Technical impossibility to achieve the percutaneous approach to the vertebra to treat.
• Vertebral pedicle diameter or height of treated vertebra(e) not sufficient regarding balloon kyphoplasty TROCATHETER size. This should be assessed through prescreening MRI and/or CT-Scan
• More than three symptomatic vertebral compression fractures in the same vertebral segment.
• Patient receiving additional local treatment within 15 days after balloon kyphoplasty procedure (surgery, radiofrequency, radiotherapy).
• Patient with primary bone tumors (eg : osteosarcoma) or single solitary plasmocytoma (patients presenting those tumors on other parts of the body, other than VCF are eligible).
• Patients presenting sclerotic or mixed vertebral lesions(sclerotic vertebral lesions at another vertebral level are not a contraindication).
• Patients with less than 3 month life expectancy
• Patient undergoing an experimental anti-cancerous treatment in Phase I evaluated at the same time
• Patient having relevant co-morbidities which may interfere with the data management on pain and quality of life.
• Patient presenting an inadequate vertebra with Balloon Kyphoplasty.
• Patient undergoing an additional treatment other than balloon kyphoplasty for their vertebral fracture.
• Patient presenting neurological signs or spinal cord compression or spinal canal narrowing requiring surgical decompression;
• Patient with a medical or surgical condition not compatible with balloon kyphoplasty procedure (eg : a non-treated local infection)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Hôpital Henri Mondor - Service de Radiologie

Créteil, Val de Marne, 94000, France

Location

Hôpital Lariboisière-service de radiologie ostéoarticulaire

Paris, 75010, France

Location

Hôpital Cochin - service de radiologie

Paris, 75014, France

Location

Hopital Bichat -service de radiologie

Paris, 75018, France

Location

MeSH Terms

Conditions

Spinal Fractures; Multiple Myeloma

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jean-Denis LAREDO, M.D.,PR.

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Antoine FEYDY, M.D., PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: October 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2010
• Last Updated: March 24, 2015

Record last verified: 2014-11

Locations

FR (4)