Infrapatellar Approach
ProcedureInfrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
NCT Number: NCT02750072
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
University of Alberta Hospital, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
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
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.
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.
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
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.
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.
Time frame: 4, 6,12 and 24 months post treatment
5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
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.
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.
Fraser Orthopaedic Research Society
Network
Acronym: INSURT
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