Bone defect
Conditions
Interventions
Intervention group :Replantation of Deep-Frozen Autologous Bone
Control group:Artificial Bone Grafting
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Overall inclusion criteria 1. Aged between 18 and 75; 2. Be able to understand the research content and sign informed consent; 3. Patients with multi-joint lesions in the hip and knee who are scheduled to undergo joint arthroplasty and may require joint arthroplasty for the other joint as well as femoral or tibial defect repair; 4. Or patients scheduled for joint arthroplasty, with an anticipated future need for prosthesis revision and femoral or tibial defect repair; 5. Good follow-up and cooperation ability Phase A: During joint arthroplasty (bone collection and cryopreservation) 1. Meet the overall inclusion criteria for the study; 2. Be able to fully understand the research and sign the informed consent for bone removal and preservation; 3. It is expected that a sufficient amount of autologous bone can be obtained during the operation. Phase B: When bone defects occur and bone grafting is scheduled (ultimately included in the study and grouped). Common Inclusion Criteria for Both the Intervention Group (Autologous Bone Group) and the Control Group (Artificial Bone Group) 1. Meet the overall inclusion criteria for the study; 2. Patients who have been diagnosed with tibial/femoral defects through clinical and imaging (X-ray /CT/MRI) and need bone defect repair; 3. The patient agrees to undergo bone transplantation surgery and signs informed consent, and selects the corresponding bone graft materials. 4. Be able to complete the prescribed follow-up during the study period and be willing to cooperate. Specific Inclusion Criteria for the Intervention Group (Autologous Bone Group) 1. The patient has previously signed consent for cryopreservation of autologous bone during Phase A, has stored autologous bone, and the stored autologous bone passes inventory inspection (free from contamination, within the valid preservation period, and the quantity/quality of harvested bone meets repair requirements); 2.Preoperative assessment confirms that the cryopreserved autologous bone is suitable for the intended repair site. Specific Inclusion Criteria for the Control Group (Artificial Bone Group) 1. The patient has not stored autologous bone, or the stored autologous bone is unusable due to improper preservation, requiring the use of artificial bone instead; 2. The artificial bone material used complies with the center's/study's regulations, and information such as model/batch number is recorded.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Severe systemic diseases that may affect study outcomes (e.g., immunosuppressed states (such as long-term medication, autoimmune diseases) or allergies to graft materials; severe metabolic bone diseases (such as uncontrolled hyperthyroidism, osteoporosis) or skeletal developmental abnormalities (e.g., osteogenesis imperfecta); severe cardiopulmonary diseases (e.g., heart failure Class III-IV); hepatic or renal insufficiency or coagulation disorders (e.g., hemophilia); end-stage renal disease, etc.); 2. History of failed artificial bone grafting or multiple bone grafting surgeries; 3. History of drug or alcohol abuse within 6 months prior to screening; 4. Pregnant or lactating women, or women of childbearing potential not using effective contraception; 5. Active infection (local purulent manifestations or systemic signs of infection) or positive hematological infection screening (including a. HIV RNA testing; b. Hepatitis B surface antigen (HBs-Ag); c. Hepatitis C virus antibody (HCV-Ab); d. Syphilis antibody); 6. Poor compliance of the subject, inability to complete the study for other reasons, or cases where the investigator deems the subject unsuitable for inclusion or continuation in the trial. Phase A: During joint arthroplasty (Bone Harvesting and Cryopreservation) 1. Meet the general exclusion criteria of the study; 3. Patients with severe comorbidities that may compromise the safety of bone harvesting (e.g., uncontrolled bleeding tendency, severe coagulation abnormalities); 3. Patients refusing bone harvesting or preservation (failure to sign preservation consent); 4. Cases where the investigator deems bone harvesting or preservation inappropriate (e.g., history of organ transplantation, severe immunosuppression, or other safety or ethical concerns). Phase B: When bone defects occur and bone grafting is scheduled Common Exclusion Criteria for Both the Intervention Group (Autologous Bone Group) and the Control Group (Artificial Bone Group) 1. Meet the general exclusion criteria of the study; 2. Other conditions that may affect study evaluation or safety (as determined by the investigator). Specific Exclusion Criteria for the Intervention Group (Autologous Bone Group) 1. Contamination of autologous bone (microbiological/pathological or inventory inspection failure); 2. The quantity or morphology of the preserved autologous bone is insufficient to meet repair requirements; 3. Excluded subjects will be transferred to the artificial bone group and continue the study (if applicable); if they refuse to continue, they will be considered as (withdrawn midway); Specific Exclusion Criteria for the Control Group (Artificial Bone Group) 1. Quality/compliance issues or evidence of prohibition regarding the artificial bone material; 2. Patient allergy to or refusal of the artificial bone material.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone integration;Bone healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Pain score;Immune indicators;Safety;HHS Joint Function score;KSS Joint Function score;Inflammatory indicators;SF-36 Quality of Life Score; | — |
Countries
China
Contacts
Public ContactHao Shen
Department of Orthopedics, Shanghai Sixth People's Hospital
Outcome results
None listed