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

Primary Purpose

Bone Resorption, Nerve

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Innervation
Non-innervation
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption focused on measuring Jaw reconstruction, Innervation, Bone resorption

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityRecruiting
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Innervation

Non-innervation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 11, 2019
Last Updated
February 6, 2020
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03889587
Brief Title
Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction
Acronym
INVITATION
Official Title
Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction: a Prospective Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Örebro University, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Nerve
Keywords
Jaw reconstruction, Innervation, Bone resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Innervation
Arm Type
Experimental
Arm Description
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
Arm Title
Non-innervation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Innervation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-innervation
Intervention Description
This will be the traditional method of vascularized iliac or fibular bone flaps, and neurorrhaphy will not be performed.
Primary Outcome Measure Information:
Title
The efficiency of simultaneously innervated jaw bone reconstruction for preventing graft bone resorption.
Description
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%.
Time Frame
Follow-up for 2 years after bone grafting.
Title
The index of successful innervated reconstruction.
Description
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.
Time Frame
up to 1 year follow-up after bone grafting.
Secondary Outcome Measure Information:
Title
Changes in the outer diameter of the graft bone.
Description
Measure the outer diameter of the graft bone during the surgery and 1 year after the surgery and compare the difference.
Time Frame
During surgery; After 1 years of bone grafting.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the age of 17 to 65 years (to avoid possible postmenopause osteoporosis), irrespective of gender. Post resection segmental defect of mandible between 5-9 cm long. Acceptable systemic conditions like nonmenopausal-related osteoporosis, Diabetes mellitus, in controlled normal range. Patients agreeing to sign the informed consent form. Exclusion Criteria: Advanced malignant tumors. Poor general condition, who can not tolerate vascularized bone flap reconstruction. History of drugs affecting bone metabolism, like bisphosphonates, calcium agents or others.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Lei, MD,PhD
Phone
+86 15921941601
Email
wangleizyh@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenping Zhang
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Lei, MD,PhD
Phone
+86 15921941601
Email
wangleizyh@aliyun.com
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Lei, MD,PhD
Phone
+86 15921941601
Email
wangleizyh@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28445371
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.
Results Reference
result

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Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction

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