Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

NCT04926896 | Unknown

• 1 other identifier: 2019-254
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Control Group

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Minimally invasive bone harvesting surgery

EXPERIMENTAL

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.

Procedure: Minimally invasive bone harvesting surgery

Traditional iliac crest bone harvesting surgery

PLACEBO COMPARATOR

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

Procedure: Traditional iliac crest bone harvesting surgery

Interventions

Traditional iliac crest bone harvesting surgery PROCEDURE

The experimental group and the control group do not have special requirements; perform the surgery according to the normal operation methods of different sites.

Traditional iliac crest bone harvesting surgery

Minimally invasive bone harvesting surgery PROCEDURE

Minimally invasive bone harvesting surgery

Minimally invasive bone harvesting surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• West China Hospital: collaborator
• Werner Wicker Klinik: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Hangzhou Xinrun Medical Technology Co., Ltd.

Hangzhou, Zhejiang, 311100, China

RECRUITING

Study Officials

• Yan Y Shigui, Professor

  Chief Scientist

  STUDY DIRECTOR

Central Study Contacts

Li L Wanli, M.D.

CONTACT

13967116021; liwanli@furunmed.com

Li L Hongmei

CONTACT

13857139616; lihongmei@furunmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group: Minimally invasive bone harvesting surgery group. Control group: Traditional iliac crest bone harvesting surgery group.

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: September 20, 2020
• Primary Completion: September 21, 2024
• Study Completion: December 21, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

CN (1)