Safety Study of Treatment of Leg Fractures (EVOS SMALL)

Multicenter, Post-market Observational Study Evaluating Safety and Efficacy of the EVOS SMALL Plating System for the Treatment of Lower Extremity Fractures

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

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens Orthopedic Clinic
  • Texas
    • Fort Worth, Texas, United States, 76104
      • John Peter Smith Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Treatment; EVOS SMALL PLating System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events		1 year
Disability Rating Index (DRI)	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"	1 year
EuroQoL-5D Questionnaire	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"	1 year
Pain using visual analog scale (VAS)	level of pain as marked on a 100 mm line by subject with 0mm representing "no pain" and 100mm representing "worst possible pain"	1 year
Number of complications relating to surgery		1 year
Number of hospital readmissions for any reason		1 year

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): March 24, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: surgery; fracture; tibial fracture; Tibia; internal fixation; open reduction; EVOS; EVOS SMALL; plating system; plates
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: 2018.18.TMA.EVOSM.PRO.EXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No