Innervation of Vascularized Iliac Transplant Avoids Resorption in Jaw Bone Reconstruction

NCT03889587 | Unknown DMC

• 1 other identifier: 20180506
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Resorption; Nerve

Keywords

Jaw reconstruction; Innervation; Bone resorption

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in the outer diameter of the graft bone.

  During surgery; After 1 years of bone grafting.

Study Arms (2)

Innervation

EXPERIMENTAL

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

Non-innervation

ACTIVE COMPARATOR

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

Interventions

Innervation PROCEDURE

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.

Innervation

Non-innervation PROCEDURE

This will be the traditional method of vascularized iliac or fibular bone flaps, and neurorrhaphy will not be performed.

Non-innervation

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Örebro University, Sweden: collaborator

Study Sites (2)

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

Shanghai, 200011, China

RECRUITING

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

Shanghai, 200011, China

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 28445371 RESULT

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Chenping Zhang

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Wang Lei, MD,PhD

CONTACT

+86 15921941601; wangleizyh@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 26, 2019
• Study Start: May 8, 2019
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)