Clinical trial NCT03889587: Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction
Official title: Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction: a Prospective Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Nerve
Keywords: Jaw reconstruction
Innervation
Bone resorption
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
First posted: 2019-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients between the age of 17 to 65 years (to avoid possible postmenopause osteoporosis), irrespective of gender.
2. Post resection segmental defect of mandible between 5-9 cm long.
3. Acceptable systemic conditions like nonmenopausal-related osteoporosis, Diabetes mellitus, in controlled normal range.
4. Patients agreeing to sign the informed consent form.

Exclusion Criteria:

1. Advanced malignant tumors.
2. Poor general condition, who can not tolerate vascularized bone flap reconstruction.
3. History of drugs affecting bone metabolism, like bisphosphonates, calcium agents or others.

Primary outcomes:
measure: The efficiency of simultaneously innervated jaw bone reconstruction for preventing graft bone resorption.
timeFrame: Follow-up for 2 years after bone grafting.
measure: The index of successful innervated reconstruction.
timeFrame: up to 1 year follow-up after bone grafting.
Secondary outcomes:
measure: Changes in the outer diameter of the graft bone.
timeFrame: During surgery; After 1 years of bone grafting.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Chenping Zhang
role: STUDY_CHAIR
References:
citation: Wang L, Wei JH, Yang X, Yang ZH, Sun MY, Cheng XB, Xu LQ, Lei DL, Zhang CP. Preventing Early-Stage Graft Bone Resorption by Simultaneous Innervation: Innervated Iliac Bone Flap for Mandibular Reconstruction. Plast Reconstr Surg. 2017 May;139(5):1152e-1161e. doi: 10.1097/PRS.0000000000003263.