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

January 26, 2024 updated by: Fraser Orthopaedic Research Society
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital / Fraser Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8L 8E7
        • Hamilton Health Sciences
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5C 1R6
        • St. Michael's Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4, 6, 12 and 24 months post treatment
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.
4, 6, 12 and 24 months post treatment
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, 6, 12 and 24 months post treatment
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.
4, 6, 12 and 24 months post treatment
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.
4, 6,12 and 24 months post treatment
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
4, 6,12 and 24 months post treatment
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.
4, 6, 12 and 24 months post treatment
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.
Intra-operatively and 4, 6,12 and 24 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Orthopaedic Research Society

Investigators

  • Principal Investigator: Alan Johnstone, Professor, Aberdeen Royal Infirmary
  • Principal Investigator: Trevor B Stone, MD, FRCSC, Royal Columbian Hospital / Fraser Health Authority
  • Principal Investigator: Darius G Viskontas, MD, FRCSC, Royal Columbian Hospital / Fraser Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2016

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

October 12, 2023

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimated)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHREB #: 2016-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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