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Observational Patient Registry of the Dynamic Locking Screws (DLS)

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ClinicalTrials.gov Identifier: NCT02656628
Recruitment Status : Withdrawn (Due to the voluntary recall of the study device (DLS 3.7mm and DLS 5.0mm))
First Posted : January 15, 2016
Last Update Posted : January 21, 2016
Sponsor:
Collaborator:
Synthes Australia Pty Ltd
Information provided by (Responsible Party):
Synthes GmbH

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.

Condition or disease Intervention/treatment
Proximal or Diaphyseal Humerus Fracture Diaphyseal or Distal Femur Fracture Diaphyseal, Distal or Proximal Tibia Fracture Device: Dynamic Locking Screw 3.7mm and 5.0mm

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official 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
Study Start Date : May 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Fractures of humerus femur tibia
Dynamic Locking Screw 3.7mm and 5.0mm
Device: Dynamic Locking Screw 3.7mm and 5.0mm
Treatment with DLS and locked plate constructs (small or large fragments)




Primary Outcome Measures :
  1. Radiographic callus formation and location of callus evaluation: Change over time [ Time Frame: 6 weeks, 12 weeks, 6 months, and (12)* months ]

    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



Secondary Outcome Measures :
  1. Fracture union [ Time Frame: 6 weeks, 12 weeks, 6 months, and (12)* months ]

    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


  2. QuickDASH for patients with humerus fracture [ Time Frame: Time point: 6 and 12 weeks, 6 and (12)* months ]

    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


  3. WOMAC for patients with femur and tibia fractures [ Time Frame: Time point: 6 and 12 weeks, 6 and (12)* months ]

    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


  4. Full weight bearing or full use of the upper extremity [ Time Frame: 6 and 12 weeks, 6 and (12)* months ]

    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


  5. Adverse Events related to the device or procedure [ Time Frame: intra-and postoperative; 6 and 12 weeks; 6 and (12)* months ]

    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


  6. General adverse events not related to the device or procedure [ Time Frame: postoperative; 6 and 12 weeks; 6 and (12)* months ]

    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


  7. Secondary surgical interventions due to device or procedure related Adverse events [ Time Frame: postoperative; 6 and 12 weeks; 6 and (12)* months ]

    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


  8. Health related quality of life: EuroQoL (EQ-5D) [ Time Frame: Baseline; 6 and 12 weeks; 6 and (12)* months ]

    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who meet the in- and exclusion criteria and have signed an informed patient consent prior to surgery will be included.
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656628


Locations
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Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Brisbane, Queensland, Australia, 4102
Sponsors and Collaborators
Synthes GmbH
Synthes Australia Pty Ltd

Additional Information:

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Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT02656628     History of Changes
Other Study ID Numbers: STU-TRA-T-08-198-03
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Humeral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries
Arm Injuries