Safety Study of Treatment of Leg Fractures

NCT03881241 | Terminated

• 1 other identifier: 2018.18.TMA.EVOSM.PRO.EXT
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tibial Fractures

Keywords

Tibia; fracture; EVOS; EVOS SMALL; plating system; plates; tibial fracture; surgery; open reduction; internal fixation

Outcome Measures

Primary Outcomes (1)

• Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System

  1 year

Secondary Outcomes (6)

• Number of adverse events

  1 year

• Disability Rating Index (DRI)

  1 year

• EuroQoL-5D Questionnaire

  1 year

• Pain using visual analog scale (VAS)

  1 year

• Number of complications relating to surgery

  1 year

Study Arms (1)

Study Treatment

EVOS SMALL PLating System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female subject who is 18 years of age or older at the time of signing the informed consent.
• 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.
• 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.
• Subject is willing and able to attend all study visits including 1 year post-operative follow-up.

You may not qualify if:

• Subject has contraindications or hypersensitivity to the use of the EVOS SMALL Plating System or its components (316L stainless steel).
• 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.
• Subject has, in the opinion of the Investigator, an emotional or neurologic condition that precludes cooperation and compliance with the rehabilitation regimen.
• Subject is currently in another investigational drug, biologic, or device study or has been treated with an investigational product within the last 30 days.
• Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Tibial Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Rachel Nelson

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Study Start: September 20, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

US (2)