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
|Condition or disease|
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|
|Estimated Enrollment :||14 participants|
|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|
EVOS SMALL PLating System
- Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System [ Time Frame: 1 year ]
- Number of adverse events [ Time Frame: 1 year ]
- 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"
- 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"
- 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"
- Number of complications relating to surgery [ Time Frame: 1 year ]
- Number of hospital readmissions for any reason [ Time Frame: 1 year ]
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
|Contact: Natasha Schappellemail@example.com|