Clinical Randomized Controlled Study on the Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    336
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 20 August 2022

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.

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.

Details
Condition Control Group
Treatment Traditional iliac crest bone harvesting surgery, Minimally invasive bone harvesting surgery
Clinical Study IdentifierNCT04926896
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on20 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with clinical bone defects or need for bone fusion
Age 18 to 65, and gender is not limited
Informed consent has been signed

Exclusion Criteria

Age less than 18 or greater than 65
Patients with severe deformities of the iliac bone or extensive defects of the iliac bone, which are not suitable for bone extraction
Patients with coagulation dysfunction
Patients who are unwilling to perform iliac bone extraction
BMI & lt; = 18.5 kg/m2
Patients with type I and type II diabetes
Osteoporosis(T & lt; = -2.5)
Moderate and severe anemia(hemoglobin & lt; 9g/L) or hypoproteinemia(albumin & lt; 30g/L)
Patients with malignant neoplasms; Patients with mental illness and those who are unconscious and unable to express themselves accurately
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