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The Parapatellar Approach to Intramedullary Tibial Nailing

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
ClinicalTrials.gov Identifier:
NCT01407718
First received: July 27, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition
Knee Pain Intermittent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Parapatellar Approach to Intramedullary Tibial Nailing: Is There a Difference in Anterior Knee Pain When Compared to a Traditional Flexed Approach?

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • incidence of anterior knee pain in the approaches used for tibial nailing [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be indicated for intramedullary tibial nailing according to their fracture pattern.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407718

Locations
United States, Utah
University of Utah Orthopedics Center
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Erik Kubiak, MD University of Utah Orthapedics
  More Information

No publications provided

Responsible Party: Eric Kubiak, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01407718     History of Changes
Other Study ID Numbers: 43060
Study First Received: July 27, 2011
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Knee pain
tibial nailing

ClinicalTrials.gov processed this record on November 25, 2014