Clinical trial NCT02750072: INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Official title: INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Anterior Knee Pain Syndrome
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2016-04-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS (visual analog scale) for pain on kneeling/ability to knee
timeFrame: 12 months post treatment
Secondary outcomes:
measure: AKT (Aberdeen Kneeling Weight-Distribution Test)
timeFrame: 4, 6, 12 and 24 months post treatment
measure: AST (Aberdeen Standing Weight-Distribution Test)
timeFrame: 4, 6, 12 and 24 months post treatment
measure: VAS (Visual Analog Scale) at rest, with walking and descending stairs
timeFrame: 4, 6, 12 and 24 months post treatment
measure: Lysholm Knee Scoring Scale
timeFrame: 4, 6, 12 and 24 months post treatment
measure: PKPM (Photographic knee pain map)
timeFrame: 4, 6,12 and 24 months post treatment
measure: EQ-5D Health Related Quality of Life Outcome Measure
timeFrame: 4, 6,12 and 24 months post treatment
measure: WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem
timeFrame: 4, 6, 12 and 24 months post treatment
measure: Radiographic outcome
timeFrame: Intra-operatively and 4, 6,12 and 24 months post treatment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital / Fraser Health Authority
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Royal Columbian Hospital / Fraser Health Authority
name: Darius G Viskontas, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Columbian Hospital / Fraser Health Authority
name: Trevor B Stone, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Aberdeen Royal Infirmary
name: Alan Johnstone, Professor
role: PRINCIPAL_INVESTIGATOR
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