Suspended

A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

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What is being tested

DLS 5.0 (Dynamic locking screws)

+ SLS (Standard locking screw)

Device
Who is being recruted

Leg Injuries+3

+ Wounds and Injuries

+ Fractures, Bone

From 21 to 120 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAO Innovation Translation Center
Last updated: August 13, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.

NCT01693367
Principal SponsorAO Innovation Translation Center
Last updated: August 13, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Leg InjuriesWounds and InjuriesFractures, BoneFemoral Fractures, DistalFemoral FracturesPeriprosthetic Fractures

Criteria

7 inclusion criteria required to participate
21 years and older
Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
Ability to walk independently prior to injury
Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
Show More Criteria
13 exclusion criteria prevent from participating
Active malignancy
Additional ipsi- or contralateral lower extremity fracture
Any kind of implant at the ipsilateral proximal femur
Any not medically managed severe systemic disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
ORIF with DLS 5.0 (Dynamic Locking Screws)

Group II

Active Comparator
ORIF with SLS (Standard locking screw)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

UC Davis Medical Center

Sacramento, United StatesOpen UC Davis Medical Center in Google Maps

University of Missouri Orthopaedics

Columbia, United States

Washington University Orthopedics

St Louis, United States

Hospital of the University of Pennsylvania

Philadelphia, United States
Suspended12 Study Centers