Broken LegNCT02728362
Suprapatellar Nailing of Tibial Shaft Fractures
An observational study of Broken Leg, run by Corewell Health West.
Trial summary
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Broken Leg
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jan 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with tibial shaft fractures.
Who may be able to join
- Isolated, unilateral tibial shaft fractures
- Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
- age 18-65, including pregnant women
- open or closed fractures
- able to sign consent
- english speaking
Who cannot join
- compartment syndrome
- other lower extremity injuries that will affect functional outcomes
- problems maintaining follow up (homeless, not willing to return for follow up)
- pathological fractures
- prisoners
- previous retained hardware in the injured leg
- injuries requiring vascular repair
About this study
Official title: Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.
Read the detailed description
Suprapatellar nailing...
Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.
Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.
Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:
- To evaluate the long term presence of knee pain
- To evaluate the long term functional outcomes
- Conditions
- Broken Leg
- Keywords
- tibial shaft fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term presence of knee pain
During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain.
Measured: 10 years
Secondary outcomes (3)
Long term functional outcomes
During follow up visits participants will be administered the Lysholm knee score and the PROMIS Mobility measure. These forms will be analyzed together to determine the overall long term function of the participants.
Measured: 10 years
Knee Range of Motion (ROM)
During follow up visits the participants knee ROM will be measured
Measured: 10 years
Fracture Healing
During follow up visits fracture healing will be evaluated
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Broken LegStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blake W Miller, DO, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728362
- Sponsor's protocol ID
- 2016-027
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2016
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up
- ClinicalTrials.gov ID
- NCT02728362
- Acronym / sponsor ID
- 2016-027
- Conditions
- Broken Leg
- Keywords
- tibial shaft fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 5 Apr 2016 (estimated)
- 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.
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.
Detailed description
Suprapatellar nailing...
Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.
Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.
Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:
- To evaluate the long term presence of knee pain
- To evaluate the long term functional outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with tibial shaft fractures.
Key inclusion criteria (6 listed)
- Isolated, unilateral tibial shaft fractures
- Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
- age 18-65, including pregnant women
- open or closed fractures
- able to sign consent
Key exclusion criteria (7 listed)
- compartment syndrome
- other lower extremity injuries that will affect functional outcomes
- problems maintaining follow up (homeless, not willing to return for follow up)
- pathological fractures
- prisoners
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
Long term presence of knee pain
Time frame: 10 years
During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain.
3 secondary outcomes
Long term functional outcomes
Time frame: 10 years
Knee Range of Motion (ROM)
Time frame: 10 years
Fracture Healing
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Blake W Miller, DO principal investigator
Corewell Health West
Questions about this trial
What is this clinical trial studying?
An observational study of Broken Leg, run by Corewell Health West.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long term presence of knee pain (time frame: 10 years). 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 18 Oct 2023.