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

Not Applicable

Recruiting

• Conditions: Fracture, Comminuted; Fracture Tibia; Fracture Femur
• Interventions: Device: Fracture reposition with 3D printed patient specific repositions guides

• Registration Number: NCT05741892
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Study Start: 2023-04-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D fracture reposition guide group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinik für Orthopädische Chirurgie und Traumatologie; 🇨🇭 Bern, Switzerland