Clinical trial NCT04926896: Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect
Official title: Clinical Randomized Controlled Study on the Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Control Group
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Werner Wicker Klinik
name: Tongji Hospital
First posted: 2021-06-15
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group:

Minimally invasive bone harvesting surgery group.

Control group:

Traditional iliac crest bone harvesting surgery group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the VAS score of pain in the donor site
timeFrame: 24 hours after the operation
measure: the comprehensive curative effect
timeFrame: 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Xinrun Medical Technology Co., Ltd.
state: Zhe Jiang
Study officials:
affiliation: Chief Scientist
name: Yan Y Shigui, Professor
role: STUDY_DIRECTOR
References: