Knee Pain IntermittentNCT01407718
The Parapatellar Approach to Intramedullary Tibial Nailing
An observational study of Knee Pain Intermittent, run by University of Utah at 1 site in United States.
Trial summary
This project will address the incidence of anterior knee pain in the approaches used for tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be compared to the approaches in which nail insertion requires the knee to be placed in flexion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Pain Intermittent
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be indicated for intramedullary tibial nailing according to their fracture pattern.
Who may be able to join
- All patients, 18 years of age or older, who present to the University of Utah Medical Center for treatment of a tibia fracture that requires use of an intramedullary nail for fracture fixation.
Who cannot join
- prior operations about the knee
- neurovascular compromise
- ipsilateral fracture of the femur or proximal tibia not amenable to intramedullary nailing
- patients who are non-ambulatory
- patients who have ipsilateral fractures involving the ankle or foot
- a fracture pattern that requires the surgeon to use a surgical approach outside the assigned treatment arm.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics Center
Salt Lake City, Utah, 84121
About this study
Official title: The Parapatellar Approach to Intramedullary Tibial Nailing: Is There a Difference in Anterior Knee Pain When Compared to a Traditional Flexed Approach?
This project will address the incidence of anterior knee pain in the approaches used for tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be compared to the approaches in which nail insertion requires the knee to be placed in flexion. The incidence of anterior knee pain will be compared in each group to assess whether the compared approaches result in similar levels of anterior knee pain. Patients will be given the 2000 IKDC Subjective Knee Evaluation Form to assess anterior knee pain. The 2000 IKDC Subjective Knee Evaluation Form is a newer assessment tool created by the International Knee Documentation Committee. It has been validated for use with broad patient populations dealing with various knee disorders.19
Read the detailed description
In the population affected by orthopaedic injury, fractures of the tibial shaft are the most common of all long bone fractures. This fracture pattern occurs approximately 26 times per 100,000 people and accounts for 77,000 hospitalizations per annum.(1, 2) Intramedullary nailing is the most common operative treatment choice for fractures of the diaphyseal tibia (tibial shaft). Intramedullary nailing is also commonly used for shaft fractures that extend into the metaphyses (excluding fractures that extend into the knee and/or exhibit comminution at the ankle joint).
Tibial nails are inserted at or about the knee. Three different insertion approaches are used as standard of care at this institution, including the transtendinous, peritendinous, and parapatellar approach. In all three techniques, the nail is placed in the tibia in the same manner: after fracture reduction, the proper entry point in the proximal tibia is found and the tibia is sequentially reamed until a suitable nail can be passed and locked in place with interlocking screws. The three named approaches vary the (1) angulation of the knee at the time of insertion and the (2) location of the incision and soft tissue dissection, relative to the patellar tendon, necessary to locate the proper entry point for the nail. Tibial nails are inserted with the knee in flexion (bent to ~90°) for the transtendinous and peritendinous approaches, and in relative extension (less than 30°) for the parapatellar approach. For insertion, the transtendinous and peritendinous approaches require dissections that allow the nail to be passed through or around the patellar tendon. In the parapatellar technique, dissection is carried out juxtaposed to the patella.
Anterior knee pain is the most common complication of intramedullary tibial nailing. It has been reported in a range of 10% to 86% with average follow up of two years.(3) Review of current literature regarding the subject of anterior knee pain and tibial nailing reveals four commonly attributable causes: skin incision location,(4,5) approach in reference to the patellar tendon,(6-9) nail insertion site,(10) and nail prominence.(11-13) No study has specifically examined whether knee angulation at the time of insertion impacts anterior knee pain.
- Conditions
- Knee Pain Intermittent
- Keywords
- Knee pain, tibial nailing
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of anterior knee pain in the approaches used for tibial nailing
This project will address the incidence of anterior knee pain in the approaches used for tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be compared to the approaches in which nail insertion requires the knee to be placed in flexion
Measured: 6 months after surgery
Secondary outcomes (1)
compare knee pain levels in patients whose tibial fractures required intramedullary nailing and were treated using a parapatellar approach
The purpose of this prospective study is to compare knee pain levels in patients whose tibial fractures required intramedullary nailing and were treated using a parapatellar approach (knee flexed ~30 degrees) or a traditional approach requiring full flexion of the knee (transtendinous and peritendinous approaches utilize flexion of ~90 degrees).
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain IntermittentStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rothberg, University of Utah
- Investigators
- David Rothberg, MD, Principal investigator, University of Utah Orthapedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407718
- Sponsor's protocol ID
- 43060
- Status last verified
- Jun 2021
- First submitted
- 27 Jul 2011
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Parapatellar Approach to Intramedullary Tibial Nailing: Is There a Difference in Anterior Knee Pain When Compared to a Traditional Flexed Approach?
- ClinicalTrials.gov ID
- NCT01407718
- Acronym / sponsor ID
- 43060
- Conditions
- Knee Pain Intermittent
- Keywords
- Knee pain, tibial nailing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 2 Aug 2011 (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.
This project will address the incidence of anterior knee pain in the approaches used for tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be compared to the approaches in which nail insertion requires the knee to be placed in flexion. The incidence of anterior knee pain will be compared in each group to assess whether the compared approaches result in similar levels of anterior knee pain. Patients will be given the 2000 IKDC Subjective Knee Evaluation Form to assess anterior knee pain. The 2000 IKDC Subjective Knee Evaluation Form is a newer assessment tool created by the International Knee Documentation Committee. It has been validated for use with broad patient populations dealing with various knee disorders.19
Detailed description
In the population affected by orthopaedic injury, fractures of the tibial shaft are the most common of all long bone fractures. This fracture pattern occurs approximately 26 times per 100,000 people and accounts for 77,000 hospitalizations per annum.(1, 2) Intramedullary nailing is the most common operative treatment choice for fractures of the diaphyseal tibia (tibial shaft). Intramedullary nailing is also commonly used for shaft fractures that extend into the metaphyses (excluding fractures that extend into the knee and/or exhibit comminution at the ankle joint).
Tibial nails are inserted at or about the knee. Three different insertion approaches are used as standard of care at this institution, including the transtendinous, peritendinous, and parapatellar approach. In all three techniques, the nail is placed in the tibia in the same manner: after fracture reduction, the proper entry point in the proximal tibia is found and the tibia is sequentially reamed until a suitable nail can be passed and locked in place with interlocking screws. The three named approaches vary the (1) angulation of the knee at the time of insertion and the (2) location of the incision and soft tissue dissection, relative to the patellar tendon, necessary to locate the proper entry point for the nail. Tibial nails are inserted with the knee in flexion (bent to ~90°) for the transtendinous and peritendinous approaches, and in relative extension (less than 30°) for the parapatellar approach. For insertion, the transtendinous and peritendinous approaches require dissections that allow the nail to be passed through or around the patellar tendon. In the parapatellar technique, dissection is carried out juxtaposed to the patella.
Anterior knee pain is the most common complication of intramedullary tibial nailing. It has been reported in a range of 10% to 86% with average follow up of two years.(3) Review of current literature regarding the subject of anterior knee pain and tibial nailing reveals four commonly attributable causes: skin incision location,(4,5) approach in reference to the patellar tendon,(6-9) nail insertion site,(10) and nail prominence.(11-13) No study has specifically examined whether knee angulation at the time of insertion impacts anterior knee pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be indicated for intramedullary tibial nailing according to their fracture pattern.
Key inclusion criteria (1 listed)
- All patients, 18 years of age or older, who present to the University of Utah Medical Center for treatment of a tibia fracture that requires use of an intramedullary nail for fracture fixation.
Key exclusion criteria (6 listed)
- prior operations about the knee
- neurovascular compromise
- ipsilateral fracture of the femur or proximal tibia not amenable to intramedullary nailing
- patients who are non-ambulatory
- patients who have ipsilateral fractures involving the ankle or foot
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
incidence of anterior knee pain in the approaches used for tibial nailing
Time frame: 6 months after surgery
This project will address the incidence of anterior knee pain in the approaches used for tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be compared to the approaches in which nail insertion requires the knee to be placed in flexion
1 secondary outcome
compare knee pain levels in patients whose tibial fractures required intramedullary nailing and were treated using a parapatellar approach
Time frame: 1 year after surgery
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 Jun 2021.
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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.
David Rothberg, MD principal investigator
University of Utah Orthapedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain Intermittent, run by University of Utah at 1 site 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 1 inclusion and 6 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
incidence of anterior knee pain in the approaches used for tibial nailing (time frame: 6 months after surgery). 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 Jun 2021.