Tibial FracturesEVOS SMALLNCT03881241
Safety Study of Treatment of Leg Fractures
An observational study of Tibial Fractures, run by Smith & Nephew, Inc. at 2 sites in United States.
Trial summary
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2019to 24 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years and older having either proximal or distal tibial fractures.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Athens Orthopedic Clinic
Athens, Georgia, 30606
John Peter Smith Hospital
Fort Worth, Texas, 76104
About this study
Official title: 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.
Read the 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.
- Conditions
- Tibial Fractures
- Keywords
- Tibia, fracture, EVOS, EVOS SMALL, plating system, plates, tibial fracture, surgery, open reduction, internal fixation
- Medical subject headings
- Tibial Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | EVOS SMALL PLating System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System
Measured: 1 year
Secondary outcomes (6)
Number of adverse events
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 1 year
Number of complications relating to surgery
Measured: 1 year
Number of hospital readmissions for any reason
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start20 Sep 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Nelson, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881241
- Sponsor's protocol ID
- 2018.18.TMA.EVOSM.PRO.EXT
- Acronym
- EVOS SMALL
- Status last verified
- Apr 2020
- First submitted
- 11 Mar 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Post-market Observational Study Evaluating Safety and Efficacy of the EVOS SMALL Plating System for the Treatment of Lower Extremity Fractures
- ClinicalTrials.gov ID
- NCT03881241
- Acronym / sponsor ID
- EVOS SMALL / 2018.18.TMA.EVOSM.PRO.EXT
- Conditions
- Tibial Fractures
- Keywords
- Tibia, fracture, EVOS, EVOS SMALL, plating system, plates, tibial fracture, surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty with enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | – | –EVOS SMALL PLating System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years and older having either proximal or distal tibial fractures.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System
Time frame: 1 year
6 secondary outcomes
Number of adverse events
Time frame: 1 year
Disability Rating Index (DRI)
Time frame: 1 year
EuroQoL-5D Questionnaire
Time frame: 1 year
Pain using visual analog scale (VAS)
Time frame: 1 year
Number of complications relating to surgery
Time frame: 1 year
Number of hospital readmissions for any reason
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Nelson study chair
Smith & Nephew, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Fractures, run by Smith & Nephew, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty with enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation rate for any reason of the lower extremity fractures treated operatively with the EVOS SMALL Plating System (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.