Benign bone neoplasms
Conditions
Interventions
240 patients with benign bone tumors will be submitted to curettage or partial resection and grouped into 4 types of tumor presentation. For each presentation, two types of treatment will be randomise
In large subchondral lesions (near the joint), the filling with porous cement and solid cement (30 patients in each group) will be compared
In metadiaphyseal lesions (distal to the joint), of less than 30 years old patients, the elastic bone fixation with thinner plate and fewer screws and the rigid safety fixation (more robust and with m
In patients, older than 30 years the reinforced elastic plate (more robust, but with a long interval between the central screws) and the rigid safety fixation (robust with screws close to the bone def
Procedure/surgery
E07.858.442.660
Sponsors
Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão
Eligibility
Inclusion criteria
Inclusion criteria: Patients of any age and sex will be included; with benign bone tumors B2 and B3 according to the classification of Enneking; located in the long bones of upper or lower limbs and that require surgical treatment by curettage. Curettage indication consists of impending fracture; pain and size increase or progression of the lesion.
Exclusion criteria
Exclusion criteria: Patients with complete pathological fracture with deviation; multiple lesions that compromise the patient's function; systemic bone diseases; metadiaphyseal defects accessed through small windows smaller than 1/8 of the perimeter; proximal femur metadiaphyseal lesions with medial cortex (calcar) discontinuity in less than 30 years old patients or who refuses to participate in the study will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New bone formation rate in bone defects created by curettage. Evaluated using specific software to calculate the area in serial radiographs of the operated segment and at each incidence, 1, 2, 3, 6 and 9 months after surgery and annually and in the computed tomography before and 6 months after surgery. It will be measured only in the groups treated with porous cement or left unfilled with or without the use of bone fixation. It is expected a difference between rates of at least 20%, 6 months after surgery. In the case of the solid cement control group, only the osteointegration of the solid or porous cement blocks will be analyzed. The rate of osseointegration should be at least 20% higher with the use of porous cement than with solid cement 6 months after surgery. Complications rate identified at regular postoperative visits with special attention to delayed gait initiation, pain, and fractures. The complication rate is expected to be equal to or less than in the control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of bone remodeling patterns according to the region, fixation elasticity, and age, analyzed by serial radiographs (1, 2, 3, 6, 9 and 12 months post-op) and by computed tomography (6 months post-op). Identification of the period in which the bone remodeling process is active by serial radiographs. | — |
Countries
Brazil
Contacts
Public ContactEdgard Engel
Hospital das Clínicas da Faculdade de Medicina de Ribeirão
Outcome results
None listed