Control Group
Conditions
Brief summary
In this research, a new bone harvesting technique is introduced in order to find an iliac crest bone harvesting method for patients with less trauma, less postoperative pain in donor sites, and lower incidence of postoperative complications, so as to get ideal bone grafting materials at a small cost, enhance the effect of osteogenesis repair on bone defect or fusion site, and improve the operation quality.
Detailed description
Based on the domestic and foreign research on minimally invasive bone harvesting, we have developed a disposable battery-powered bone harvesting device that can be used for milling bone tissues. Using this disposable battery-powered bone harvesting device, cancellous bone milling can be performed in a small bone hole with a diameter of 7.5 mm. The morselized bone or bone chips it milled can be used for bone fusion at the desired site. The technique adopts patented milling tool bit and electric drive, with high operation efficiency, so the surgery can be completed very quickly. The bone trauma in the operation can be significantly reduced and the pain in the donor site can be greatly alleviating. Moreover, the technique can obviously reduce the duration of bone harvesting and the cost of operating room. In addition, significant reductions in postoperative pain will also be helpful to a range of clinical advantages and benefits, such as the average hospitalization days, and will be expected to benefit significantly in patients undergoing autologous bone harvesting.
Interventions
PROCEDURETraditional iliac crest bone harvesting surgery
The experimental group and the control group do not have special requirements; perform the surgery according to the normal operation methods of different sites.
PROCEDUREMinimally invasive bone harvesting surgery
Minimally invasive bone harvesting surgery
Sponsors
West China Hospital
Werner Wicker Klinik
Tongji Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental group: Minimally invasive bone harvesting surgery group. Control group: Traditional iliac crest bone harvesting surgery group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with clinical bone defects or need for bone fusion; 2. Age 18 to 65, and gender is not limited; 3. Informed consent has been signed.
Exclusion criteria
1. Age less than 18 or greater than 65; 2. Patients with severe deformities of the iliac bone or extensive defects of the iliac bone, which are not suitable for bone extraction; 3. Patients with coagulation dysfunction; 4. Patients who are unwilling to perform iliac bone extraction; 5. BMI & lt; = 18.5 kg/m2; 6. Patients with type I and type II diabetes; 7. Osteoporosis(T & lt; = -2.5); 8. Moderate and severe anemia(hemoglobin & lt; 9g/L) or hypoproteinemia(albumin & lt; 30g/L); 9. Patients with malignant neoplasms; Patients with mental illness and those who are unconscious and unable to express themselves accurately.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the comprehensive curative effect | 6 months after the operation | the healing rate of the bone graft site |
| the VAS score of pain in the donor site | 24 hours after the operation | the VAS score of pain in the donor site |
Countries
China
Contacts
Primary ContactLi L Wanli, M.D.
Backup ContactLi L Hongmei
Outcome results
None listed