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

Primary Purpose

Tibial Fractures, Anterior Knee Pain Syndrome

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Infrapatellar Approach
Suprapatellar Approach
Sponsored by
Fraser Orthopaedic Research Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta Hospital
  • Royal Columbian Hospital / Fraser Health Authority
  • Hamilton Health Sciences
  • The Ottawa Hospital
  • St. Michael's Hospital
  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infrapatellar approach

Semi-extended suprapatellar approach

Arm Description

Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).

Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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.
PKPM (Photographic knee pain map)
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
5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
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.
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.

Full Information

First Posted
April 18, 2016
Last Updated
September 11, 2023
Sponsor
Fraser Orthopaedic Research Society
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1. Study Identification

Unique Protocol Identification Number
NCT02750072
Brief Title
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Acronym
INSURT
Official Title
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2016 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Orthopaedic Research Society

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Anterior Knee Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infrapatellar approach
Arm Type
Active Comparator
Arm Description
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Arm Title
Semi-extended suprapatellar approach
Arm Type
Experimental
Arm Description
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Intervention Type
Procedure
Intervention Name(s)
Infrapatellar Approach
Intervention Description
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Intervention Type
Procedure
Intervention Name(s)
Suprapatellar Approach
Intervention Description
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
Primary Outcome Measure Information:
Title
VAS (visual analog scale) for pain on kneeling/ability to knee
Description
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
Time Frame
12 months post treatment
Secondary Outcome Measure Information:
Title
AKT (Aberdeen Kneeling Weight-Distribution Test)
Description
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.
Time Frame
4, 6, 12 and 24 months post treatment
Title
AST (Aberdeen Standing Weight-Distribution Test)
Description
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.
Time Frame
4, 6, 12 and 24 months post treatment
Title
VAS (Visual Analog Scale) at rest, with walking and descending stairs
Description
Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale
Time Frame
4, 6, 12 and 24 months post treatment
Title
Lysholm Knee Scoring Scale
Description
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.
Time Frame
4, 6, 12 and 24 months post treatment
Title
PKPM (Photographic knee pain map)
Description
Used to determine the precise location of the knee pain, as indicated and localized by the participant.
Time Frame
4, 6,12 and 24 months post treatment
Title
EQ-5D Health Related Quality of Life Outcome Measure
Description
5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
Time Frame
4, 6,12 and 24 months post treatment
Title
WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem
Description
A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities.
Time Frame
4, 6, 12 and 24 months post treatment
Title
Radiographic outcome
Description
Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail.
Time Frame
Intra-operatively and 4, 6,12 and 24 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darius G Viskontas, MD, FRCSC
Organizational Affiliation
Royal Columbian Hospital / Fraser Health Authority
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trevor B Stone, MD, FRCSC
Organizational Affiliation
Royal Columbian Hospital / Fraser Health Authority
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Johnstone, Professor
Organizational Affiliation
Aberdeen Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Columbian Hospital / Fraser Health Authority
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

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