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Safety Study of Treatment of Leg Fractures (EVOS SMALL)

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ClinicalTrials.gov Identifier: NCT03881241
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.

Condition or disease
Tibial Fractures

Detailed Description:

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the EVOS SMALL Plating System in subjects with proximal or distal (pilon or ankle) tibial fractures. Subjects will be recruited in the hospital emergency room or surgical department, at the point of identification of the need for ORIF surgery, and the decision is made to use the EVOS SMALL Plating System. The choice of medical and surgical treatment will be made independently by the Investigator in the regular course of practice and will not be influenced by this study protocol.

Approximately 100 subjects will be enrolled in order to ensure at least 90 evaluable subjects, with a minimum of 45 evaluable subjects having either a) proximal or b) distal tibial fractures.

Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative fracture resolution according to standard radiological practice (X-rays), clinical complications, reoperation rate, DRI, EQ-5D-5L, and pain VAS.


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Study Type : Observational
Estimated Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter, Post-market Observational Study Evaluating Safety and Efficacy of the EVOS SMALL Plating System for the Treatment of Lower Extremity Fractures
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : May 26, 2021
Estimated Study Completion Date : May 26, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Study Treatment
EVOS SMALL PLating System



Primary Outcome Measures :
  1. Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 1 year ]
  2. Disability Rating Index (DRI) [ Time Frame: 1 year ]
    Change in subject's ease of mobility as marked on a 100 mm line by subject with the far left indicating "without difficulty" and the far right indicating "not at all"

  3. EuroQoL-5D Questionnaire [ Time Frame: 1 year ]
    Change in quality of life from baseline to one year postoperatively by answering quality of life questions on a 1-5 scale with 1 representing "never" and 5 representing "always"

  4. Pain using visual analog scale (VAS) [ Time Frame: 1 year ]
    level of pain as marked on a 100 mm line by subject with 0mm representing "no pain" and 100mm representing "worst possible pain"

  5. Number of complications relating to surgery [ Time Frame: 1 year ]
  6. Number of hospital readmissions for any reason [ Time Frame: 1 year ]


Information from the National Library of Medicine

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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
Subjects 18 years and older having either proximal or distal tibial fractures.
Criteria

Inclusion Criteria:

  1. Male or female subject who is 18 years of age or older at the time of signing the informed consent.
  2. Subject provides an Institutional Review Board (IRB)-approved informed consent. The subject must have the physical and mental capacity to provide informed consent for him/herself.
  3. Subject has experienced proximal tibial fracture (OTA Type 41 A-C) or distal tibial fracture (OTA 43 Type A-C) with or without fibular/malleolar involvement (OTA 44 A-C) and are scheduled for ORIF using the EVOS SMALL Plating System.
  4. Subject is willing and able to attend all study visits including 1 year post-operative follow-up.

Exclusion Criteria:

  1. Subject has contraindications or hypersensitivity to the use of the EVOS SMALL Plating System or its components (316L stainless steel).
  2. Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or retard healing, such as blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross bony distortion of the tibia, as detailed in the IFU.
  3. Subject has, in the opinion of the Investigator, an emotional or neurologic condition that precludes cooperation and compliance with the rehabilitation regimen.
  4. Subject is currently in another investigational drug, biologic, or device study or has been treated with an investigational product within the last 30 days.
  5. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

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): NCT03881241


Contacts
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Contact: Natasha Schappell 817-302-3949 natasha.schappell@smith-nephew.com

Sponsors and Collaborators
Smith & Nephew, Inc.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03881241     History of Changes
Other Study ID Numbers: 2018.18.TMA.EVOSM.PRO.EXT
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Smith & Nephew, Inc.:
Tibia
fracture
EVOS
EVOS SMALL
plating system
plates
tibial fracture
surgery
open reduction
internal fixation

Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries