Clinical trial NCT03881241: Safety Study of Treatment of Leg Fractures
Official title: Multicenter, Post-market Observational Study Evaluating Safety and Efficacy of the EVOS SMALL Plating System for the Treatment of Lower Extremity Fractures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tibial Fractures
Keywords: Tibia
fracture
EVOS
EVOS SMALL
plating system
plates
tibial fracture
surgery
open reduction
internal fixation
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years and older having either proximal or distal tibial fractures.

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

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.

Eligibility 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.

Primary outcomes:
measure: Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System
timeFrame: 1 year
Secondary outcomes:
measure: Number of adverse events
timeFrame: 1 year
measure: Disability Rating Index (DRI)
timeFrame: 1 year
measure: EuroQoL-5D Questionnaire
timeFrame: 1 year
measure: Pain using visual analog scale (VAS)
timeFrame: 1 year
measure: Number of complications relating to surgery
timeFrame: 1 year
measure: Number of hospital readmissions for any reason
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
Study officials:
affiliation: Smith & Nephew, Inc.
name: Rachel Nelson
role: STUDY_CHAIR
References: