Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

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

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.

Study Overview

• Status: Recruiting
• Conditions: Control Group
• Intervention / Treatment: Procedure: Minimally invasive bone harvesting surgery; Procedure: Traditional iliac crest bone harvesting surgery

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 Type: Interventional
• Enrollment (Estimated): 336
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li L Wanli, M.D.; Phone Number: 13967116021; Email: liwanli@furunmed.com
• Study Contact Backup: Name: Li L Hongmei; Phone Number: 13857139616; Email: lihongmei@furunmed.com

Study Locations

• China
  • Zhe Jiang
    • Hangzhou, Zhe Jiang, China, 311100
      • Recruiting
      • Hangzhou Xinrun Medical Technology Co., Ltd.
      • Contact: Li L Wanli, M.D.; Phone Number: 13967116021; Email: liwanli@furunmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally invasive bone harvesting surgery; .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.; 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.; 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.; .Scrap and collect the cancellous bone by tool bit during operation.; . After collecting sufficient amount of cancellous bone, turn off the power, screw out the cabin, and pour out the cancellous bone.; . Suturing the iliac crest periosteum and deep fascia, closing the incision layer by layer, no drainage.	Procedure: Minimally invasive bone harvesting surgery; Minimally invasive bone harvesting surgery
Placebo Comparator: Traditional iliac crest bone harvesting surgery; .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.; Use a bone chisel to open a lid on the iliac crest ridge cortex ,open the cover length at 3cm.; Lift the iliac crest ridge cortex plate cover, use bone knife and scraper to harvest bone in the iliac bone marrow cavity.; 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.; After collecting sufficient amount of cancellous bone, suturing the iliac crest periosteum and deep fascia, closing the incision layer by layer, no drainage	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the VAS score of pain in the donor site	the VAS score of pain in the donor site	24 hours after the operation
the comprehensive curative effect	the healing rate of the bone graft site	6 months after the operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: West China Hospital; Tongji Hospital; Werner Wicker Klinik
• Investigators: Study Director: Yan Y Shigui, Professor, Chief Scientist

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Estimated): September 21, 2024
• Study Completion (Estimated): December 21, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019-254

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No