Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

Not Applicable

Recruiting

• Conditions: Control Group
• Interventions: Procedure: Minimally invasive bone harvesting surgery; Procedure: Traditional iliac crest bone harvesting surgery

• Registration Number: NCT04926896
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-23
• Last Update Posted: 2023-09-26
• Primary Completion: 2024-09-21
• Study Completion: 2024-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally invasive bone harvesting surgery	Minimally invasive bone harvesting surgery	1. .Applying routine approach in iliac crest bone harvesting surgery, make a 4cm long incision before or after the iliac crest, slice skin and subcutaneous tissue by layer., exposing the iliac crest ridge, outer plate and part of the iliac crest bone. 2. Use the cortical bone opening device to open two bone holes with a diameter of 7.5 mm side by side in the iliac bone cortex ,place disposable battery-powered bone harvesting device for iliac crest bone harvesting operations. 3. The direction of the tool bit should be parallel to the outer iliac plate, to avoid penetration of inner iliac layer, and avoid the injury to iliac blood vessels, nerves or internal organs. 4. .Scrap and collect the cancellous bone by tool bit during operation. 5. . After collecting sufficient amount of cancellous bone, turn off the power, screw out the cabin, and pour out the cancellous bone. 6. . Suturing the iliac crest periosteum and deep fascia, closing the incision layer by layer, no drainage.
Traditional iliac crest bone harvesting surgery	Traditional iliac crest bone harvesting surgery	1. .Applying routine approach in iliac crest bone harvesting surgery, make a 4cm long incision before or after the iliac crest, slice skin and subcutaneous tissue by layer., exposing the iliac crest ridge, outer plate and part of the iliac crest bone. 2. Use a bone chisel to open a lid on the iliac crest ridge cortex ,open the cover length at 3cm. 3. Lift the iliac crest ridge cortex plate cover, use bone knife and scraper to harvest bone in the iliac bone marrow cavity. 4. Avoid violence when using bone knives and scrapers, to avoid penetration of inner iliac layer, and avoid the injury to iliac blood vessels, nerves or internal organs. 5. After collecting sufficient amount of cancellous bone, suturing the iliac crest periosteum and deep fascia, closing the incision layer by layer, no drainage

Primary Outcome Measures

Name	Time	Method
the VAS score of pain in the donor site	24 hours after the operation	the VAS score of pain in the donor site
the comprehensive curative effect	6 months after the operation	the healing rate of the bone graft site

Trial Locations

Locations (1)

Hangzhou Xinrun Medical Technology Co., Ltd.; 🇨🇳 Hangzhou, Zhe Jiang, China