3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-30

Study Completion Date

2019-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reconstruction of Complex Proximal Humeral Fractures.

NCT02052206

Osteoarthritis of the Shoulder Complexe Proximal Humeral Fractures

COMPLETED NA

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

NCT05741892

Fracture Tibia Fracture Femur Fracture, Comminuted

RECRUITING NA

Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts

NCT01532076

Osteoporotic Fractures

TERMINATED PHASE2

Identification of Microcirculation and Inflammation After Minimal-invasive Osteosynthesis of the Proximal Femur

NCT01264172

Level of Pain

COMPLETED NA

Treatment of Proximal Humerus Fractures in the Elderly

NCT02566018

Humeral Fractures

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan.

Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture of Humerus Fracture of Ulna Radius Fracture of Clavicle Fracture of Hand Fracture of Pelvis Fracture of Femur Fracture of Tibia Fibula Fracture of Skull

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient specific guides

fracture fixation with 3D planning and use of patient-specific instruments

Group Type EXPERIMENTAL

fracture fixation with patient specific guides

Intervention Type DEVICE

Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation

standard procedure

standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments

Group Type ACTIVE_COMPARATOR

standard procedure of fracture fixation

Intervention Type DEVICE

the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fracture fixation with patient specific guides

Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation

Intervention Type DEVICE

standard procedure of fracture fixation

the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MyOsteotomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
* clinical indication for a computed tomography of the fractured bone
* \>18 years of Age
* Patient is able to give informed consent

Exclusion Criteria

* pregnancy or nursing women
* non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
* participation in a different clinical Trial within the last 30 days before inclusion or during the study
* allergy to Polyamid PA 2200
* no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
* Applying the medical device is not possible, because of technical or anatomical reasons.
* other clinical significant accompanying symptoms (tumor, infection)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No