INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

Conditions
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Tibial Fractures, Anterior Knee Pain Syndrome

Intervention / Treatment
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* Procedure: Infrapatellar Approach
* Procedure: Suprapatellar Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all extra-articular tibial fractures simple distal tibial intra-articular fractures amenable to IMN open and closed fractures bilateral tibiae willing and able to consent, follow protocol and attend follow-up visits able to read and understand English or have interpreter available Exclusion Criteria: patients with contralateral femur and/or hip fracture requiring retrograde IMN patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period associated knee injury previous symptomatic knee pathology ipsilateral injuries to the same limb that would interfere with rehab or outcome neurovascular injuries at the level of the knee requiring surgery open or closed fractures > 14 days (times of injury to OR) non unions pathologic fractures periprosthetic fractures spinal injury non-ambulatory patients incarceration limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy) likely problems, in the judgment of the investigators, with maintaining follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infrapatellar approach<br>Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral). | Procedure: Infrapatellar Approach<br>* Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)<br>|
| Experimental: Semi-extended suprapatellar approach<br>Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve). | Procedure: Suprapatellar Approach<br>* Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visual analog scale) for pain on kneeling/ability to knee | 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 | 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKT (Aberdeen Kneeling Weight-Distribution Test) | 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. | 4, 6, 12 and 24 months post treatment | 
| AST (Aberdeen Standing Weight-Distribution Test) | 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. | 4, 6, 12 and 24 months post treatment | 
| VAS (Visual Analog Scale) at rest, with walking and descending stairs | Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale | 4, 6, 12 and 24 months post treatment | 
| Lysholm Knee Scoring Scale | 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. | 4, 6, 12 and 24 months post treatment | 
| PKPM (Photographic knee pain map) | Used to determine the precise location of the knee pain, as indicated and localized by the participant. | 4, 6,12 and 24 months post treatment | 
| EQ-5D Health Related Quality of Life Outcome Measure | 5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression | 4, 6,12 and 24 months post treatment | 
| WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem | A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities. | 4, 6, 12 and 24 months post treatment | 
| Radiographic outcome | Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail. | Intra-operatively and 4, 6,12 and 24 months post treatment |