Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

Control Group Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926896
• Other study ID #: 2019-254
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: December 21, 2024

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Li L Wanli, M.D.
• Phone: 13967116021
• Email: liwanli[@]furunmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: December 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Control Group

Intervention

Procedure:
• Traditional 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.
• Minimally invasive bone harvesting surgery
Minimally invasive bone harvesting surgery

Locations

Country	Name	City	State
China	Hangzhou Xinrun Medical Technology Co., Ltd.	Hangzhou	Zhe Jiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Tongji Hospital, Werner Wicker Klinik, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the VAS score of pain in the donor site	the VAS score of pain in the donor site	24 hours after the operation
Primary	the comprehensive curative effect	the healing rate of the bone graft site	6 months after the operation