INSURT: INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- VAS (visual analog scale) for pain on kneeling/ability to knee [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
Secondary Outcome Measures
- AKT (Aberdeen Kneeling Weight-Distribution Test) [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) [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 [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 [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) [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
all extra-articular tibial fractures
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simple distal tibial intra-articular fractures amenable to IMN
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open and closed fractures
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bilateral tibiae
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willing and able to consent, follow protocol and attend follow-up visits
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able to read and understand English or have interpreter available
Exclusion Criteria:
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patients with contralateral femur and/or hip fracture requiring retrograde IMN
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patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
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associated knee injury
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previous symptomatic knee pathology
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ipsilateral injuries to the same limb that would interfere with rehab or outcome
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neurovascular injuries at the level of the knee requiring surgery
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open or closed fractures > 14 days (times of injury to OR)
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non unions
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pathologic fractures
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periprosthetic fractures
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spinal injury
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non-ambulatory patients
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incarceration
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limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
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likely problems, in the judgment of the investigators, with maintaining follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta Hospital | Edmonton | Alberta | Canada | |
| 2 | Royal Columbian Hospital / Fraser Health Authority | New Westminster | British Columbia | Canada | V3L 3W7 |
| 3 | Hamilton Health Sciences | Hamilton | Ontario | Canada | L8L 8E7 |
| 4 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1Y 4E9 |
| 5 | St. Michael's Hospital | Toronto | Ontario | Canada | M5C 1R6 |
| 6 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 |
Sponsors and Collaborators
- Fraser Orthopaedic Research Society
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
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- FHREB #: 2016-029