Broken LegNCT02510339
Tibial Shaft Nailing Treated With Suprapatellar Nailing
An observational study of Broken Leg, run by Orlando Health, Inc..
Trial summary
The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Broken Leg
- What is being tested?
- Observation
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2016to 1 Mar 2017
- 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: The study population will include skeletally mature patients of Level One Orthopaedics, presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft.
Who may be able to join
- skeletally mature
- open or closed fractures of the tibial shaft
Who cannot join
- concomitant tibial plateau or tibial pilon injuries
- a knee dislocation
- skeletally immature
- those who will undergo standard (infra-patellar) tibial nailing
About this study
Official title: The Incidence of Associated Intra-articular Knee Pathology With Concomitant Tibial Shaft Fractures Treated With Suprapatellar Nailing
The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.
Read the detailed description
Suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. Additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. An undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. Long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature.
The primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint.
As a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to Orlando Regional Medical Center.
- Conditions
- Broken Leg
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Administration of two questionnairs during post operative visits.
| Study group | Role | What they receive |
|---|---|---|
| Observational | The Lysholm Knee score and the SF-36 questionnairs will be given to patients presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft during their follow up visits post operativily. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consequences of suprapatellar tibial nailing
During follow up visits, subjects will be given the Olerud-Molander questionnaire to complete. The data from that form will be analyzed for each visit.
Measured: One year
Secondary outcomes (2)
Incidences of intra-articular knee pathology
Post-operative radiographs will be analyzed during each visit per standard of care.
Measured: One year.
Functional assessment
The functional assessment/progress of the patient will be noted at each follow up visit.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start10 Jan 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula J. Harriott, Orlando Health, Inc.
- Investigators
- Tara Roberts, BS, Study chair, Orlando Health IRB corporate manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510339
- Sponsor's protocol ID
- 15.047.04
- Status last verified
- Oct 2015
- First submitted
- 8 Jul 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Associated Intra-articular Knee Pathology With Concomitant Tibial Shaft Fractures Treated With Suprapatellar Nailing
- ClinicalTrials.gov ID
- NCT02510339
- Acronym / sponsor ID
- 15.047.04
- Conditions
- Broken Leg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 29 Jul 2015 (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.
The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.
Detailed description
Suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. Additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. An undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. Long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature.
The primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint.
As a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to Orlando Regional Medical Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationThe Lysholm Knee score and the SF-36 questionnairs will be given to patients presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft during their follow up visits post operativily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include skeletally mature patients of Level One Orthopaedics, presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft.
Key inclusion criteria (2 listed)
- skeletally mature
- open or closed fractures of the tibial shaft
Key exclusion criteria (4 listed)
- concomitant tibial plateau or tibial pilon injuries
- a knee dislocation
- skeletally immature
- those who will undergo standard (infra-patellar) tibial nailing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationAdministration of two questionnairs during post operative visits. | Other | Observational |
Primary outcome
Consequences of suprapatellar tibial nailing
Time frame: One year
During follow up visits, subjects will be given the Olerud-Molander questionnaire to complete. The data from that form will be analyzed for each visit.
2 secondary outcomes
Incidences of intra-articular knee pathology
Time frame: One year.
Functional assessment
Time frame: One year
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 10 Apr 2017.
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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.
Tara Roberts, BS study chair
Orlando Health IRB corporate manager
Questions about this trial
What is this clinical trial studying?
An observational study of Broken Leg, run by Orlando Health, Inc..
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 2 inclusion and 4 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 10 Apr 2017. 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?
Consequences of suprapatellar tibial nailing (time frame: One 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 2017.