Study Stopped
Due to the voluntary recall of the study device (DLS 3.7mm and DLS 5.0mm)
Observational Patient Registry of the Dynamic Locking Screws
DLS
A Multi-Center Prospective, Observational Patient Registry of the Dynamic Locking Screws in Metaphyseal and Diaphyseal Shaft Fractures of the Humerus, Femur and Tibia
1 other identifier
observational
N/A
1 country
1
Brief Summary
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedJanuary 21, 2016
January 1, 2016
1.5 years
July 4, 2014
January 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic callus formation and location of callus evaluation: Change over time
The radiologic presence of callus at the four locations around the plate is overall evaluated by a central independent trauma fellow or radiologist: * Lateral (under the plate) * Medial (on the contra lateral cortex) * Anterior * Posterior "\*"for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
6 weeks, 12 weeks, 6 months, and (12)* months
Secondary Outcomes (8)
Fracture union
6 weeks, 12 weeks, 6 months, and (12)* months
QuickDASH for patients with humerus fracture
Time point: 6 and 12 weeks, 6 and (12)* months
WOMAC for patients with femur and tibia fractures
Time point: 6 and 12 weeks, 6 and (12)* months
Full weight bearing or full use of the upper extremity
6 and 12 weeks, 6 and (12)* months
Adverse Events related to the device or procedure
intra-and postoperative; 6 and 12 weeks; 6 and (12)* months
- +3 more secondary outcomes
Study Arms (1)
Fractures of humerus femur tibia
Dynamic Locking Screw 3.7mm and 5.0mm
Interventions
Treatment with DLS and locked plate constructs (small or large fragments)
Eligibility Criteria
Patients who meet the in- and exclusion criteria and have signed an informed patient consent prior to surgery will be included.
You may qualify if:
- Age: ≥18 years
- Any of the following fracture types:
- Proximal or diaphyseal humerus fracture
- Diaphyseal or distal femur fracture
- Diaphyseal, distal or proximal tibia fracture
- Eligible for treatment with Synthes DLS and locked plate constructs (small or large fragments)
- Patients able and willing to sign informed consent form
- Patients able and willing to adhere to 12-months follow-up visits
You may not qualify if:
- Polytrauma
- Pregnant or nursing females
- Patients already participating in an investigational trial
- Patients who are not expected to survive the follow-up period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Synthes GmbHlead
- Synthes Australia Pty Ltdcollaborator
Study Sites (1)
Princess Alexandra Hospital
Woolloongabba, Brisbane, Queensland, 4102, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
January 15, 2016
Study Start
May 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
January 21, 2016
Record last verified: 2016-01