AzTrials
AzTrials

Bone LossEarly Phase 1NCT04449211

The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant

A Early Phase 1 study testing Implantation in people with Bone Loss and Defect Limb, run by Cho Ray Hospital at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Loss, Defect Limb
What is being tested?
Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteVietnam
Study dates
6 Oct 2023to 30 Dec 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants with health insurance regardless of sex having bone defect greater than 5cm due to trauma or tumour resection agree to participate the research

Who cannot join

  • Participants with contraindication to surgery
  • Participants do not agree to undergo surgery
  • Participants with local infection or soft tissue defect

Trial locations and contacts

1 site in 1 country.

Hung Do Phuoc, MD, PhD contact

+84903775579

dphungcr@ump.edu.vn

Phu Nguyen Hoang, MD, MSc contact

+84938689292

nguyenhoangphu@ump.edu.vn

Vietnam1 site, 1 recruiting

  • Cho Ray hospital

    Ho Chi Minh City, 700000

    Hung Do Phuoc, MD, PhD, +84903775579, dphungcr@yahoo.com

    Phu Nguyen Hoang, MD, MSc, +84938689292, nguyenhoangphu@ump.edu.vn

    Recruiting

Other trials in Vietnam

About this study

Official title: The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant

To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults

Read the detailed description

The participant with long bone defect or bone tumor of the extremity is referred to the Radiology Department to have a full CT-scan of both limbs to facilitate the later reconstruction. With the contralateral limb CT-scan data, the implant is designed with appropriate geometry and structures through online meetings with the scientists of CSIRO, Australia. Through this discussion, the supporting guides for the precise osteotomy will also be designed and would be 3D-printed later by 3 Dimensional Tech Vision Limited Company (Vietnam) with Poly Lactic Acid material. The 3D-printed metal parts will be manufactured using Titanium - 6 Aluminum - 4 Vanadium ELI (Extra Low Interstitial) material with Electron Beam Melting technology in CSIRO (Australia). Subsequently, the 3D-printed part will undergo mechanical tests using the Instron 5500R system (Australia) to validate its required mechanical properties. If this metal part cannot fulfill the mechanical requirements, the problematic geometry will be revised and re-designed. Another prototype will be 3D-printed with the same protocol and be tested until it qualified for the mechanical requirement. When the 3D-printed model passes the mechanical test, another 3D-printed metal part with a similar design will be manufactured before transferring to 3-Dimensional Tech Vision Limited Company (Vietnam) for post-processing, surface finishing, sterilising, packaging, labeling. Eventually, the implant will be sent to Cho Ray hospital. The amount of intraoperative blood loss and operative time will be recorded.

Being tested
Implantation
Keywords
bone defect, 3D-printed Titanium alloy implant, Electron Beam Melting, customised implant, patient-specific implant
Medical subject headings
Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImplantationDevice

    Also called Bone defect implant

    Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant

Study groups in NCT04449211
Study groupRoleWhat they receive
Participants with massive bone defectExperimentalAdult participants with health insurance regardless of sex having bone defect greater than 5cm due to trauma or tumour resection agree to participate the research. The customised 3D-Printed implant is manufactured and undergoes post-processing treatment before being ready for implantation surgery.
Receives: Device: Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional outcome of the upper limb

    For the participant with bone defect of the upper limb, the Disabilities of the Arm, Shoulder, and Hand (DASH) score will be used to evaluate for the limb functional outcome. The scale is ranging from 0 (no disability) to 100 (most severe disability).

    Measured: 1 to 12 months

  2. Functional outcome of the lower limb

    For the participant with bone defect of the lower limb, the Karlstrom \& Olerud score will be used to evaluate for the limb functional outcome. The scale is graded as: bad, fair, good, excellent functional outcome.

    Measured: 1 to 12 months

  3. Radiological imaging

    the bone healing process is evaluated by the change in dual energy CT-scan result

    Measured: Post-operative day 1 to 12 months

Secondary outcomes (1)

  1. Complications

    Rate of complications

    Measured: through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start6 Oct 2023
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective participants with health insurance admitted to the Orthopaedic and Traumatology Department of Cho Ray hospital who get the diagnosis of bone defect greater than 5cm due to trauma or tumour resection.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04449211
Sponsor's protocol ID
ChoRayH
Status last verified
Aug 2024
First submitted
22 Jun 2020
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Limited data are available only to research providing high quality (of sufficient details as to be useful for research purposes) and accessible (able to be acquired and used) data for research. Those data also include the deidentified data such as X-Ray, CT-scan, MRI, etc. and do not include any identified information

Publications

  • Nauth A, McKee MD, Einhorn TA, Watson JT, Li R, Schemitsch EH. Managing bone defects. J Orthop Trauma. 2011 Aug;25(8):462-6. doi: 10.1097/BOT.0b013e318224caf0.

    PubMed 21738065

  • Keating JF, Simpson AH, Robinson CM. The management of fractures with bone loss. J Bone Joint Surg Br. 2005 Feb;87(2):142-50. doi: 10.1302/0301-620x.87b2.15874. No abstract available.

    PubMed 15736731

  • Kironde E, Sekimpi P, Kajja I, Mubiri P. Prevalence and patterns of traumatic bone loss following open long bone fractures at Mulago Hospital. OTA Int. 2019 Mar 12;2(1):e015. doi: 10.1097/OI9.0000000000000015. eCollection 2019 Mar.

    PubMed 33937651

  • Le LC, Blum RW. Road traffic injury among young people in Vietnam: evidence from two rounds of national adolescent health surveys, 2004-2009. Glob Health Action. 2013 Jan 17;6:1-9. doi: 10.3402/gha.v6i0.18757.

    PubMed 23336620

  • Ivers RQ, Nguyen HT, La QN. Status of road safety and injury burden: Vietnam. J Orthop Trauma. 2014;28 Suppl 1:S50-1. doi: 10.1097/BOT.0000000000000098. No abstract available.

    PubMed 24858002

  • Masquelet AC, Begue T. The concept of induced membrane for reconstruction of long bone defects. Orthop Clin North Am. 2010 Jan;41(1):27-37; table of contents. doi: 10.1016/j.ocl.2009.07.011.

    PubMed 19931050

  • Iacobellis C, Berizzi A, Aldegheri R. Bone transport using the Ilizarov method: a review of complications in 100 consecutive cases. Strategies Trauma Limb Reconstr. 2010 Apr;5(1):17-22. doi: 10.1007/s11751-010-0085-9. Epub 2010 Mar 9.

    PubMed 20360874

  • Belthur MV, Conway JD, Jindal G, Ranade A, Herzenberg JE. Bone graft harvest using a new intramedullary system. Clin Orthop Relat Res. 2008 Dec;466(12):2973-80. doi: 10.1007/s11999-008-0538-3. Epub 2008 Oct 8.

    PubMed 18841433

  • Cricchio G, Lundgren S. Donor site morbidity in two different approaches to anterior iliac crest bone harvesting. Clin Implant Dent Relat Res. 2003;5(3):161-9. doi: 10.1111/j.1708-8208.2003.tb00198.x.

    PubMed 14575632

  • Robertson PA, Wray AC. Natural history of posterior iliac crest bone graft donation for spinal surgery: a prospective analysis of morbidity. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1473-6. doi: 10.1097/00007632-200107010-00018.

    PubMed 11458153

  • Campana V, Milano G, Pagano E, Barba M, Cicione C, Salonna G, Lattanzi W, Logroscino G. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014 Oct;25(10):2445-61. doi: 10.1007/s10856-014-5240-2. Epub 2014 May 28.

    PubMed 24865980

  • Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.

    PubMed 23247591

  • de Alencar PG, Vieira IF. BONE BANKS. Rev Bras Ortop. 2015 Nov 16;45(6):524-8. doi: 10.1016/S2255-4971(15)30297-4. eCollection 2010 Nov-Dec.

    PubMed 27026958

  • Mauffrey C, Barlow BT, Smith W. Management of segmental bone defects. J Am Acad Orthop Surg. 2015 Mar;23(3):143-53. doi: 10.5435/JAAOS-D-14-00018.

    PubMed 25716002

  • Matsuno H, Yokoyama A, Watari F, Uo M, Kawasaki T. Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. Biomaterials. 2001 Jun;22(11):1253-62. doi: 10.1016/s0142-9612(00)00275-1.

    PubMed 11336297

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Implantation in people with Bone Loss and Defect Limb, run by Cho Ray Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hung Do Phuoc, MD, PhD (+84903775579, dphungcr@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome of the upper limb (time frame: 1 to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04449211, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in