NCT04926896

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Control Group

Interventions

Type	Name	Description
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.
PROCEDURE	Minimally invasive bone harvesting surgery	Minimally invasive bone harvesting surgery

Timeline

• Start date: 2020-09-20
• Primary completion: 2024-09-21
• Completion: 2024-12-21
• First posted: 2021-06-15
• Last updated: 2023-09-26

Locations

1 site across 1 country: China