Tumor bone defect
Conditions
Interventions
Sponsors
Xi 'an Honghui Hospital, Shaanxi Province
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects had to meet all of the following criteria to be eligible for the study. (1) The subject's condition meets one of the following conditions: 1.Single or multiple lacunar bone defects in extremities or pelvis; 2. The volume of tumor bone defect was 5-60 ml; 3. Short segmental bone defect (< 7cm); 4. Neoplastic bone defects include enchondroma, bone cyst, aneurysmal bone cyst, giant cell tumor of bone, chondromyxoid fibroma and chondroblastoma. ; (2) Age of 12 to 75 years old, male or female; Subjects (or their legal representatives) agreed to be treated and voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Those with one of the following conditions cannot be included in this trial: 1. severe conditions of bone defects, such as: segmental bone defects = 7cm in length, bone defects that cannot be immediately implemented with local soft tissue coverage. 2. Systemic or local uncontrolled foci of acute or chronic infection. 3. Bone defects caused by open trauma. 4. Malignant bone tumours after biopsy or diagnostic resection. 5. Uncontrolled diabetes mellitus (HBA1c>=8.0% and fasting glucose GLU>=7.0mmol/L). 6. Patients with abnormal liver and renal function (e.g., ALT and AST exceeding 1.5 times the upper limit of the standard, Cr exceeding the upper limit of normal and the abnormality is judged to be clinically significant by the investigator); 7. Subjects with other systemic serious diseases such as malignant tumours of other organs; 8. History of previous myeloproliferative diseases, e.g., chronic granulocytic leukaemia, essential thrombocythemia, etc; 9. suffering from systemic inflammatory diseases and/or coagulation disorders 10. patients with uncontrolled severe anaemia (HGB = 89 g/L); 11. Subjects are receiving steroid medication, thyroxine therapy; 12. Subjects who have received or plan to receive radiotherapy treatment; 13. Expected survival =3; 16. patients who are participating in other clinical studies or who have been treated in other clinical studies within 30 days prior to the screening visit; 17. other circumstances deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether the porous bioceramic particle implant and its internal fixation device were fixed in position at 6 months after operation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether the porous bioceramic particle implant and its internal fixation device were fixed in position at 1, 3, 6, and 12 months after operation;After surgery Changes in health status relative to preoperative values;Postoperative visual analogue scale pain score during movement/rest;SF-12 quality of life;The excellent and good rate of functional recovery of the adjacent joints at the surgical site after operation;Values of change from baseline in degradation of implant material and new bone formation;MSTS93 functional score;Non-grade A wound healing rate and total postoperative drainage volume; | — |
Countries
China
Contacts
Public ContactZhichao Tong
Xi 'an Honghui Hospital, Shaanxi Province
Outcome results
None listed