3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care (3DFRG)

3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care - a Prospective Case Series

The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.

Study Overview

• Status: Recruiting
• Conditions: Fracture Tibia; Fracture Femur; Fracture, Comminuted
• Intervention / Treatment: Device: Fracture reposition with 3D printed patient specific repositions guides

Detailed Description

The 3D planning of surgeries and their execution with 3D printed templates adapted to the individual patient is an established procedure for elective surgeries such as corrective osteotomies for mal-united fractures. Currently, the planning and production of 3D templates are performed mainly by external companies. The duration until delivery usually exceeds four weeks. Therefore, it is not possible to use them in acute cases (e.g. acute fractures) that need to be treated surgically within a few days.

The most frequent postoperative deformity in long bone shaft fractures is malrotation. In femoral fractures, clinically relevant rotational errors (>15°) occur in up to 40% of cases after surgical treatment, which either results in a poor clinical outcome or requires revision surgery. In tibial diaphyseal fractures, up to 50% of rotational errors have been reported. The higher the degree of comminution the higher the chances of malrotation postoperatively. Due to the comminuted situation, no reliable bony references exist intraoperatively and the surgeon can only estimate the correct length, axis and, rotation based on the contralateral leg. This ultimately leads to a high number of revision surgeries or poor outcomes. Porcine and human cadaveric feasibility studies conducted by the study team utilizing site 3D planned and printed reduction guides showed excellent accuracy of fracture reduction.

This project aims to apply this technique to the clinical setting by conducting a clinical study. The accuracy of 3D planned surgery performed with surgical guides designed and printed at the point of care will be assessed and the complication rate will be compared to the known literature.

It was hypothesized that the mean deviation between the measured postoperative rotational alignment and planned rotation alignment in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 5°. Additionally, it was hypothesized that the rate of clinically relevant deviations between postoperative rotational alignment (e.g. 15°) and planned rotation in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 10%.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hecker Andreas, MD; Phone Number: 0041 031 632 21 11; Email: andreas.hecker@insel.ch
• Study Contact Backup: Name: Hess Silvan, MD; Phone Number: 0041 031 632 21 11; Email: silvan.hess@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Universitätsklinik für Orthopädische Chirurgie und Traumatologie
    • Contact: Andreas Hecker, MD; Phone Number: 0041 031 632 21 11; Email: andreas.hecker@insel.ch
    • Sub-Investigator: Silvan Hess, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age between 18 and 99 years
• Comminuted shaft fracture of tibia or femur
• Intact contralateral tibia or femur
• Patient willing to participate and sign the informed consent
• Clear indication of surgical treatment

Exclusion criteria:

• Refusal to sign the informed consent
• Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
• Pregnancy
• Acute tumor or previous tumor disease
• Acute infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D fracture reposition guide group; Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.	Device: Fracture reposition with 3D printed patient specific repositions guides; Comminuted tibial- or/and femur shaft fractures will be treated using 3D printed patient-specific repositions guides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational deviation (Axial plane deviation) in degree	Planned rotational alignment versus postoperative rotational alignment.	Between 1 to 7 days postoperative, depending on the patients status

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length deviation in mm	Planed length versus postoperative length	Between 1 to 7 days postoperative, depending on the patients status
Frontal plane deviation in degree	Planned varus/valgus alignment versus postoperative varus/valgus alignment	Between 1 to 7 days postoperative, depending on the patients status
Sagittal plane deviation in degree	Planned flexion/extension of the proximal and distal fracture fragments compared to the postoperative position.	Between 1 to 7 days postoperative, depending on the patients status

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Hecker Andreas, MD, Universitätsklinik für Orthopädische Chirurgie und Traumatologie

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: personalized medicine; Tibia; Femur; 3D printing; Comminuted fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Comminuted
• Other Study ID Numbers: 5364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No