The Role of Type H Vessel Formation in Induced Membrane of Patients With Critical Size Bone Defect

NCT05792371 | Unknown

• 1 other identifier: 202201532B0A3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test the role of type H vessel and investigate the mechanism of its regulation in induced membrane created by induced membrane technique in patients with open fracture, aged between 20 and 80. The main questions to answer are:

• Whether type H vessel will be critical for induced membrane-mediated bone healing?
• Whether type H vessel will be a biomarker for diagnosing bone healing in patients with open fracture?
• To find out a circulating indicator for type H vessel in patients with open fracture undergoing induced membrane technique. Participants will be enrolled to collect tissues of induced membrane and blood samples to detect type H vessel and measure the biomarkers of type H vessel, investigating their correlation with the capacity of bone healing. To avoid selection bias of treatment, the grouping will be achieved by a randomized protocol qualified clinical trial center of Chang Gung Memorial Hospital to divide into with induced membrane and without induced membrane. Researchers will compare these two groups to test our hypothesis that type H vessel in important in induced membrane and their corresponding biomarkers.

Conditions

Bone Injury

Keywords

Induced membrane; Bone healing; Type H vessel

Outcome Measures

Primary Outcomes (3)

• The participants with open fracture will be assessed by the level of type H vessel

  In each group, induced membrane and soft tissue collected at 8th weeks will be used to detect CD31 and Emcn by performing immunohistochemistry (IHC) or immunofluorescence (IF), two markers for identifying type H vessel that correlated to the capacity of bone healing. The staining will be quantified as units of intensity in values defined by software or area in pixels to assess the level of type H vessel in each participant.detecting the expression level in induced membrane and soft tissue at 8 weeks, and markers of bone healing as well as metabolites in blood of each point.

  Induced membrane will be collected at 8th weeks of IMT performing procedures of stage II.

• The participants with open fracture will be assessed by X-ray

  The defect sites in these patients will be assessed the capacity of bone healing in a time-dependent manner, by quantifying the sizes of the defects from these images and representing them as the length in centimeter (cm) or area in cm2. These results will be aggregated with the level of type H vessel to report the correlation between bone healing and type H vessel.

  Bone healing tracking will be up to 24 weeks after stage II operation.

• The participants with open fracture will be assessed the metabolic alteration

  Finding out a potential marker to predict the correlation mentioned above, bloods collected from patients in a time-dependent manner and tissue at 8th week will be assessed the metabolic alteration by performing analysis of Liquid chromatography-mass spectrometry (LC-MS/MS). The identified metabolites will be represented as a unit of concentration in micro molar. The levels of metabolites will also be aggregated with results of type H vessel and bone healing to report whether these identified metabolites will be a type H marker defining or predicting the capacity of bone healing.

  Induced membrane will be collected at 8th weeks of IMT performing procedures of stage II. Blood will be a time-dependent manner through out this study up to 32 weeks.

Study Arms (2)

with induced membrane

EXPERIMENTAL

operation of stage I and II

Procedure: induced membrane technique

without induced membrane

EXPERIMENTAL

only stage II

Procedure: Bone graft (Stage II of IMT)

Interventions

induced membrane technique PROCEDURE

Masquelet technique, also called an induced membrane technique (IMT), was first introduced to treat critical size bone defect up to 25 cm in 1986 by Pr. Alain Charles Masquelet et al. IMT is a two-stage surgical operation that recently provides a more popular option for the treatment of critical size bone defect as well as fracture nonunion. Basically, first stage of IMT comprises the implantation of a polymethylmethacrylate (PMMA) cement spacer loaded with antibiotics into defect site. During 6 to 8 weeks, this spacer induces the formation and maturation of a thin layer called induced membrane surrounding it via a foreign body immune response. In stage II, the spacer is carefully removed while keeping induced membrane at the fracture site, autologous bone graft is then performed to provoke bone healing.

Also known as: Masquelet technique

with induced membrane

Bone graft (Stage II of IMT) PROCEDURE

Bone graft is only performed in this group to provoke bone healing, as same as demonstrated in the stage II of IMT.

without induced membrane

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accept the informed consent form
• Age: 20 years to 80 years
• Type II and III open fracture with 2-6.5 cm defect size

You may not qualify if:

• Not accept the informed consent form
• Age smaller than 20 years and over 80 years
• Quit during the trial
• patients with Notifiable infectious diseases such as AIDS and hepatitis as well as cancer

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (2)

• Niikura T, Oda T, Jimbo N, Komatsu M, Oe K, Fukui T, Matsumoto T, Hayashi S, Matsushita T, Itoh T, Kuroda R. Immunohistochemical analysis revealed the expression of bone morphogenetic proteins-4, 6, 7, and 9 in human induced membrane samples treated with the Masquelet technique. J Orthop Surg Res. 2022 Jan 15;17(1):29. doi: 10.1186/s13018-022-02922-y.

  PMID: 35033126 RESULT

• Tanner MC, Boxriker S, Haubruck P, Child C, Westhauser F, Fischer C, Schmidmaier G, Moghaddam A. Expression of VEGF in Peripheral Serum Is a Possible Prognostic Factor in Bone-Regeneration via Masquelet-Technique-A Pilot Study. J Clin Med. 2021 Feb 15;10(4):776. doi: 10.3390/jcm10040776.

  PMID: 33672081 RESULT

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• HSU YUNG-HENG, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HSU YUNG-HENG, MD, PhD

CONTACT

(03)3281200; hsuyh@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 31, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: January 2, 2026
• Last Updated: March 31, 2023

Record last verified: 2023-01