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INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia (INSURT)

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ClinicalTrials.gov Identifier: NCT02750072
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Fraser Orthopaedic Fund

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
Tibial Fractures Anterior Knee Pain Syndrome Procedure: Infrapatellar Approach Procedure: Suprapatellar Approach Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Study Start Date : July 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Mauri L Zomar, CCRP 604-520-4855 mauri.zomar@fraserhealth.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Ailar Ramadi, PT, PhD    (780) 492 6713    ailar.ramadi@albertahealthservices.ca   
Principal Investigator: Matthew Menon, MD         
Canada, British Columbia
Royal Columbian Hospital / Fraser Health Authority Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Mauri Zomar, CCRP    604-520-4855    mauri.zomar@fraserhealth.ca   
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Benita Okocha, MPH, BSc    604-875-5239    Benita.Okocha@vch.ca   
Principal Investigator: Pierre Guy, MD         
Canada, Manitoba
Health Sciences Centre Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Nigar Sultana    204-787-8691    nsultana@hsc.mb.ca   
Principal Investigator: Tudor (Ted) Tufescu, MD         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Francesc Marcano, MD MSc PhD    905-527-4322 ext 44983    marcanof@mcmaster.ca   
Principal Investigator: Brad Petrisor, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Nicole Harris, BSc    613-737-8899 ext 19217    nicoharris@ohri.ca   
Principal Investigator: Steven Papp, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena (Lynn) Vicente, RN, CCRP    416.864.6060 ext 2608    vicentem@smh.ca   
Principal Investigator: Aaron Nauth, MD         
Sponsors and Collaborators
Simon Fraser Orthopaedic Fund
Investigators
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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

Publications:

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Responsible Party: Simon Fraser Orthopaedic Fund
ClinicalTrials.gov Identifier: NCT02750072     History of Changes
Other Study ID Numbers: FHREB #: 2016-029
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Patellofemoral Pain Syndrome
Wounds and Injuries
Leg Injuries
Joint Diseases
Musculoskeletal Diseases