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This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation. The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients. The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Start Date
September 13, 2016
Primary Completion Date
May 31, 2023
Completion Date
October 12, 2023
Last Updated
January 30, 2024
248
ACTUAL participants
Infrapatellar Approach
PROCEDURE
Suprapatellar Approach
PROCEDURE
Lead Sponsor
Fraser Orthopaedic Research Society
NCT05022485
NCT07006675
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06832852