Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction (INVITATION)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Resorption; Nerve
• Intervention / Treatment: Procedure: Innervation; Procedure: Non-innervation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Lei, MD,PhD; Phone Number: +86 15921941601; Email: wangleizyh@aliyun.com

Study Locations

• China
  • Shanghai, China, 200011
    • Recruiting
    • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    • Contact: Wang Lei, MD,PhD; Phone Number: +86 15921941601; Email: wangleizyh@aliyun.com
  • Shanghai, China, 200011
    • Not yet recruiting
    • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    • Contact: Wang Lei, MD,PhD; Phone Number: +86 15921941601; Email: wangleizyh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Innervation; Patients with segmental defects of mandible sized 5 to 12 cm long will be reconstructed using microsurgical iliac or fibula bone flaps. In simultaneous innervated group, neurorrhaphy between the ilioinguinal nerve or fibula flap nerve with inferior alveolar nerve or great auricular nerve will be performed. Intervention: Procedure: Innervation	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.
ACTIVE_COMPARATOR: Non-innervation; Patients with segmental defects of mandible sized 5 to 12 cm long will be reconstructed using microsurgical iliac or fibular bone flaps. In traditional noninnervated group, neurorrhaphy will not be performed. Intervention: Procedure: Non-innervation	Procedure: Non-innervation; This will be the traditional method of vascularized iliac or fibular bone flaps, and neurorrhaphy will not be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficiency of simultaneously innervated jaw bone reconstruction for preventing graft bone resorption.	The decreased ratio of the graft bone hounsfield unit calculated by Spiral CT examination ( The hounsfield unit value before bone graft - the hounsfield unit value 1 year after bone graft). It is used to reflect the degree of bone resorption. The efficiency is defined as: the decreased ratio of graft bone hounsfield unit value is less than 10%.	Follow-up for 2 years after bone grafting.
The index of successful innervated reconstruction.	The innervation and sensation in the muscle island of innervated graft bone flap will be tested using neuroelectrophysiological and needling response examination. The graft bone samples taken by hollow drilling technique during the dental implant(s) procedure will be observed by silver staining. If medullated sensory nerve fibers will be observed, then it indicates successful innervation.	up to 1 year follow-up after bone grafting.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the outer diameter of the graft bone.	Measure the outer diameter of the graft bone during the surgery and 1 year after the surgery and compare the difference.	During surgery; After 1 years of bone grafting.

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Collaborators: Örebro University, Sweden
• Investigators: Study Chair: Chenping Zhang, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 8, 2019
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Bone resorption; Jaw reconstruction; Innervation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 20180506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No