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

NCT04449211 | Recruiting Early Phase 1 DMC

• 1 other identifier: ChoRayH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Loss; Defect Limb

Keywords

bone defect; 3D-printed Titanium alloy implant; Electron Beam Melting; customised implant; patient-specific implant

Outcome Measures

Primary Outcomes (3)

• 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).

  1 to 12 months

• 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.

  1 to 12 months

• Radiological imaging

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

  Post-operative day 1 to 12 months

Secondary Outcomes (1)

• Complications

  through study completion, an average of 1 year.

Study Arms (1)

Participants with massive bone defect

EXPERIMENTAL

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. The customised 3D-Printed implant is manufactured and undergoes post-processing treatment before being ready for implantation surgery.

Device: Implantation

Interventions

Implantation DEVICE

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

Also known as: Bone defect implant

Participants with massive bone defect

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cho Ray Hospital: lead
• Commonwealth Scientific and Industrial Research Organisation, Australia: collaborator
• 3 Dimensional Tech Vision Limited Company: collaborator

Study Sites (1)

Cho Ray hospital

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Hung Do Phuoc, MD, PhD

CONTACT

+84903775579; dphungcr@ump.edu.vn

Phu Nguyen Hoang, MD, MSc

CONTACT

+84938689292; nguyenhoangphu@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 26, 2020
• Study Start: October 6, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)