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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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STU-TRA-T-08-198-03
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Universal Trial Number (UTN)
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Trial acronym
DLS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Proximal or Diaphyseal Humerus Fracture
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Diaphyseal or Distal Femur Fracture
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Diaphyseal, Distal or Proximal Tibia Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic callus formation and location of callus evaluation: Change over time
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Assessment method [1]
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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
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Timepoint [1]
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6 weeks, 12 weeks, 6 months, and (12)* months
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Secondary outcome [1]
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Fracture union
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Assessment method [1]
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The proportion of patients with a healed fracture will be assessed at each follow-up visit. Each investigator will assess locally bone healing according to the following definitions:
Union is radiographically defined as continuous mineralized bridging callus between the most distal and the most proximal fragments across the fracture site, where fracture lines are obscured.
Delayed union is defined as insufficient signs of bridging callus ie, healing has not advanced at the average rate for the location and type of fracture.
Non-union is defined as insufficient signs of bridging callus ie, healing has not advanced at the average rate for the location and type of fracture (>9 months).
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [1]
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6 weeks, 12 weeks, 6 months, and (12)* months
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Secondary outcome [2]
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QuickDASH for patients with humerus fracture
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Assessment method [2]
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The QuickDASH is a shortened version of the disabilities of the arm, shoulder and hand (DASH) outcome measure. Instead of 30 items, it uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The items ask about the degree of difficulty in performing different physical activities because of arm, shoulder or hand problems, the severity of each of the symptoms of pain, tingling, as well as the problem's impact on sleep. Each item has five response options. The score ranges from 0 (no disability) to 100 (most severe disability).
The pre-injury QuickDASH score will be assessed by asking the patient before surgery to recall the status before the injury. Additionally, the QuickDASH will be completed and compared at each follow-up visit.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [2]
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Time point: 6 and 12 weeks, 6 and (12)* months
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Secondary outcome [3]
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WOMAC for patients with femur and tibia fractures
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Assessment method [3]
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a multidimensional self-administered health status instrument to assess the dimensions of pain (five items), joint stiffness (two items), and disability (17 items).
It is among the most widely used, valid, reliable, and disease specific health outcome measure for the knee function and arthritis. The questions can either be scored on a 5-point Likert scale, on a 100mm Visual Analogue Scale (VAS), or on a 11-box Numerical Rating Scale (NRS).
In this study, the items will be scored on a 100mm VAS. The WOMAC score ranges from 0 to 96 points, where 0 equals no disability, and 96 equal's maximal disability.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [3]
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Time point: 6 and 12 weeks, 6 and (12)* months
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Secondary outcome [4]
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Full weight bearing or full use of the upper extremity
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Assessment method [4]
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The duration of postoperative non-weight bearing or postoperative inability to full use of the upper extremity will be summarized.
At each follow-up visit the proportion of patients with full weight bearing or full use of the upper extremity without restrictions will be estimated.
Full weight bearing is defined as the ability to bear the whole body weight on the affected leg.
Full use of the upper extremity is defined as the ability to use the upper extremity without any restrictions on loading.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [4]
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6 and 12 weeks, 6 and (12)* months
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Secondary outcome [5]
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Adverse Events related to the device or procedure
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Assessment method [5]
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The proportion of patients who experience adverse events (AE) related to the device or procedure within 6 and (12)* months after surgery will be estimated. The occurrence of any AE related to the device or procedure will be assessed and documented by the Investigator during 6 and (12)* months after surgery.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [5]
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intra-and postoperative; 6 and 12 weeks; 6 and (12)* months
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Secondary outcome [6]
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General adverse events not related to the device or procedure
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Assessment method [6]
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The proportion of patients who experience general AEs (not related to the device or procedure) within 6 and (12)* months after surgery will be evaluated. All general AEs will be assessed and documented by the Investigator during 6 and (12)* months after surgery.
All patients experiencing general AEs must be followed up until the symptoms subside and any clinically relevant changes have returned to baseline, or until there is a satisfactory explanation for the changes observed.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [6]
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postoperative; 6 and 12 weeks; 6 and (12)* months
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Secondary outcome [7]
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Secondary surgical interventions due to device or procedure related Adverse events
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Assessment method [7]
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All secondary surgical interventions will be documented by the Investigator during 6 and (12)* months after surgery.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [7]
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postoperative; 6 and 12 weeks; 6 and (12)* months
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Secondary outcome [8]
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Health related quality of life: EuroQoL (EQ-5D)
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Assessment method [8]
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The EQ-5D is a standardized instrument for use as a measure of health outcome. It was designed for self-completion covering the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a three-point categorical response scale: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the five dimensions. Furthermore, health state is indicated by drawing a line from the box to whichever point on the scale indicates how good or bad health state is today. The endpoints on the scale (VAS) are labeled "worst imaginable health state" and "best imaginable health state" anchored at 0 and 100 respectively.
*for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
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Timepoint [8]
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Baseline; 6 and 12 weeks; 6 and (12)* months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/05/2015
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2016
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba, Brisbane
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Recruitment postcode(s) [1]
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4102 - Woolloongabba, Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Synthes GmbH
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Synthes Australia Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02656628
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02656628
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