NCT03889587

Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction

Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction: a Prospective Comparative Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of simultaneous innervation to prevent graft bone resorption in maxillofacial reconstruction. It may provide basis for future clinical trials and new strategies for improving the functional reconstruction of large jaw bone defects.

Detailed description

The use of autograft is still the main method for reconstructing large defects of jaw bones. However, the spontaneous resorption of the graft bone is still severe, and hinders the success of dental implant(s) and chewing function even after microsurgical vascularization. But till now, there is no effective prevention method for this major problem. Based on previous studies, the investigators pioneered a simultaneous innervated vascularized iliac bone graft method, through neurorrhaphy between the nerves innervating iliac bone and recipient site. A clinical retrospective study showed that this new method significantly decreases postoperative osteoporosis, and ensures the success of dental implants (Refer to our published article Wang L\*, Wei J, Yang X, Yang Z, Sun M, Cheng X, Xu L, Lei D, Zhang C\*. Preventing early-stage graft bone resorption by simultaneous innervation: innervated iliac bone flap for mandibular reconstruction. PlastIc Reconstructive Surgery, 2017, 139(5):1152e-1161e, Cover Featured Article). The investigators intend to randomly divide the vascularized iliac bone graft cases into traditional group without innervation and simultaneous innervation group (through neurorrhaphy between the nerves innervating iliac bone flap and recipient site). The efficacy of simultaneously innervated maxillofacial reconstruction for preventing graft bone resorption will be assessed using bone mineral density test of grafted bone, as a blinded method. The innervation and sensation of the internal oblique abdominis muscle island will be tested using neuroelectrophysiological examination. The recipient nerve having the best effect on preventing bone resorption, will be determined using hierarchical comparison method.

Conditions

• Bone Resorption
• Nerve

Interventions

Type	Name	Description
PROCEDURE	Innervation	There will be simultaneous innervation of vascularized iliac or fibular bone flaps through neurorrhaphy between the nerves innervating iliac or fibular bones and recipient site.
PROCEDURE	Non-innervation	This will be the traditional method of vascularized iliac or fibular bone flaps, and neurorrhaphy will not be performed.

Timeline

• Start date: 2019-05-08
• Primary completion: 2022-04-01
• Completion: 2023-12-01
• First posted: 2019-03-26
• Last updated: 2020-02-10

Locations

2 sites across 1 country: China