Minimally invasive technique for harvesting bone from the iliac crest
Clinical Randomized Controlled Study on the Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect
This study is testing a new, less invasive way to take bone from the hip using a special tool to see if it can make the process easier and less painful for patients needing bone repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhe Jiang) |
| Trial ID | NCT04926896 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new minimally invasive technique for harvesting bone from the iliac crest using a disposable battery-powered device designed for milling bone tissues. The approach aims to reduce trauma and postoperative pain at the donor site while providing effective bone grafting materials. By utilizing a patented milling tool, the procedure is expected to be quicker and more efficient, leading to lower costs and improved surgical outcomes. The study focuses on patients requiring bone fusion or repair due to clinical bone defects.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 65 with clinical bone defects or those needing bone fusion.
Not a fit: Patients with severe iliac bone deformities, coagulation dysfunction, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce postoperative pain and complications for patients undergoing autologous bone harvesting.
How similar studies have performed: While similar minimally invasive techniques have shown promise, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhe Jiang
- Hangzhou Xinrun Medical Technology Co., Ltd. — Hangzhou, Zhe Jiang, China (Recruiting)
Study contacts
- Study coordinator: Li L Wanli, M.D.
- Email: liwanli@furunmed.com
- Phone: 13967116021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.