A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases (KYPHO-01)

Léon Bérard Center

Status and phase: Terminated; Phase 2

Conditions: Spine Metastasis; Solid Tumors

Treatments: Device: Conventional vertebroplasty; Device: Kyphoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02700308

ET14000050

Details and patient eligibility

About

Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.

The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.

Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.

In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.

To date, no data from randomized study are available in the population of cancer patients.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
• 2 metastatic sites or more;
• Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
• Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
• Pain equal or greater than 4/10 at Visual Analogic Scale
• Unstable vertebrae (SINS score equal or greater than 7;
• Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2

Exclusion criteria

• Contraindication to vertebroplasty, including contraindication to cement use;
• Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
• Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
• Neurological deficit due to medullar or radicular compression;
• Participation to another clinical trial with an analgesic intent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Conventional vertebroplasty

Active Comparator group

Description:

Conventional vertebroplasty (device's trade at the discretion of the investigator)

Treatment:

Device: Conventional vertebroplasty

Kyphoplasty

Experimental group

Description:

Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)

Treatment:

Device: Kyphoplasty