Proposal of treatment systematization for Benign Bone Tumors comparing different techniques in different forms of presentatio

Not Applicable

Recruiting

• Conditions: Benign bone neoplasms; D16.2; D16.0

• Registration Number: RBR-9c4jxp
• Lead Sponsor: niversidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ew 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.<br><br>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 Outcome Measures

Name	Time	Method
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).<br>Identification of the period in which the bone remodeling process is active by serial radiographs.