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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02656628




Registration number
NCT02656628
Ethics application status
Date submitted
4/07/2014
Date registered
15/01/2016
Date last updated
21/01/2016

Titles & IDs
Public title
Observational Patient Registry of the Dynamic Locking Screws
Scientific title
A Multi-Center Prospective, Observational Patient Registry of the Dynamic Locking Screws in Metaphyseal and Diaphyseal Shaft Fractures of the Humerus, Femur and Tibia
Secondary ID [1] 0 0
STU-TRA-T-08-198-03
Universal Trial Number (UTN)
Trial acronym
DLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal or Diaphyseal Humerus Fracture 0 0
Diaphyseal or Distal Femur Fracture 0 0
Diaphyseal, Distal or Proximal Tibia Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Dynamic Locking Screw 3.7mm and 5.0mm

Fractures of humerus femur tibia - Dynamic Locking Screw 3.7mm and 5.0mm


Treatment: Devices: Dynamic Locking Screw 3.7mm and 5.0mm
Treatment with DLS and locked plate constructs (small or large fragments)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic callus formation and location of callus evaluation: Change over time
Timepoint [1] 0 0
6 weeks, 12 weeks, 6 months, and (12)* months
Secondary outcome [1] 0 0
Fracture union
Timepoint [1] 0 0
6 weeks, 12 weeks, 6 months, and (12)* months
Secondary outcome [2] 0 0
QuickDASH for patients with humerus fracture
Timepoint [2] 0 0
Time point: 6 and 12 weeks, 6 and (12)* months
Secondary outcome [3] 0 0
WOMAC for patients with femur and tibia fractures
Timepoint [3] 0 0
Time point: 6 and 12 weeks, 6 and (12)* months
Secondary outcome [4] 0 0
Full weight bearing or full use of the upper extremity
Timepoint [4] 0 0
6 and 12 weeks, 6 and (12)* months
Secondary outcome [5] 0 0
Adverse Events related to the device or procedure
Timepoint [5] 0 0
intra-and postoperative; 6 and 12 weeks; 6 and (12)* months
Secondary outcome [6] 0 0
General adverse events not related to the device or procedure
Timepoint [6] 0 0
postoperative; 6 and 12 weeks; 6 and (12)* months
Secondary outcome [7] 0 0
Secondary surgical interventions due to device or procedure related Adverse events
Timepoint [7] 0 0
postoperative; 6 and 12 weeks; 6 and (12)* months
Secondary outcome [8] 0 0
Health related quality of life: EuroQoL (EQ-5D)
Timepoint [8] 0 0
Baseline; 6 and 12 weeks; 6 and (12)* months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Polytrauma
* Pregnant or nursing females
* Patients already participating in an investigational trial
* Patients who are not expected to survive the follow-up period

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2016
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba, Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba, Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synthes GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Synthes Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02656628
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02656628