INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia (INSURT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02750072|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : April 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tibial Fractures Anterior Knee Pain Syndrome||Procedure: Infrapatellar Approach Procedure: Suprapatellar Approach||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia|
|Actual Study Start Date :||September 13, 2016|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Active Comparator: Infrapatellar approach
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Procedure: Infrapatellar Approach
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Experimental: Semi-extended suprapatellar approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Procedure: Suprapatellar Approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
- VAS (visual analog scale) for pain on kneeling/ability to knee [ Time Frame: 12 months post treatment ]Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale
- AKT (Aberdeen Kneeling Weight-Distribution Test) [ Time Frame: 4, 6, 12 and 24 months post treatment ]The AKT involves kneeling on two separate calibrated scales for up to 60 seconds with the patient blinded to the readings. At 15-second intervals the weight distribution, measured in kg, between the two knees is documented.
- AST (Aberdeen Standing Weight-Distribution Test) [ Time Frame: 4, 6, 12 and 24 months post treatment ]The AST involves the patient standing on two separate calibrated scales (one foot on each scale) and the weight in kg recorded with the patient blinded to the readings.
- VAS (Visual Analog Scale) at rest, with walking and descending stairs [ Time Frame: 4, 6, 12 and 24 months post treatment ]Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale
- Lysholm Knee Scoring Scale [ Time Frame: 4, 6, 12 and 24 months post treatment ]Used to evaluate outcomes of knee ligament surgery using 8-items commonly affecting patients with anterior knee pain: Limp, support, locking, instability, pain, swelling, stair climbing and squatting.
- PKPM (Photographic knee pain map) [ Time Frame: 4, 6,12 and 24 months post treatment ]Used to determine the precise location of the knee pain, as indicated and localized by the participant.
- EQ-5D Health Related Quality of Life Outcome Measure [ Time Frame: 4, 6,12 and 24 months post treatment ]5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
- WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem [ Time Frame: 4, 6, 12 and 24 months post treatment ]A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities.
- Radiographic outcome [ Time Frame: Intra-operatively and 4, 6,12 and 24 months post treatment ]Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750072
|University of Alberta Hospital|
|Edmonton, Alberta, Canada|
|Canada, British Columbia|
|Royal Columbian Hospital / Fraser Health Authority|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 8E7|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 1R6|
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Darius G Viskontas, MD, FRCSC||Royal Columbian Hospital / Fraser Health Authority|
|Principal Investigator:||Trevor B Stone, MD, FRCSC||Royal Columbian Hospital / Fraser Health Authority|
|Principal Investigator:||Alan Johnstone, Professor||Aberdeen Royal Infirmary|