MRI Assessment of Cartilage Damage in Tibial Nailing
Primary Purpose
Tibial Fractures
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgical Approach - Infra-patella nailing
Surgical Approach - Supra-patella nailing
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures focused on measuring MRI, Cartilage Damage, Surgical Techniques
Eligibility Criteria
Inclusion Criteria:
- Closed tibial shaft fracture suitable for intramedullary nailing
- Able to consent
- Able to undergo MRI scanning
- Able to attend follow up for 6 months post operatively
- Suitable for surgery
Exclusion Criteria:
- Polytrauma
- Ipsilateral acute ligamentous knee injury
- A contra-indication to MRI scanning
Sites / Locations
- Addenbrooke's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Infra-patella nailing
Supra-patella nailing
Arm Description
Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach.
Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach.
Outcomes
Primary Outcome Measures
Change in cartilage appearance by MRI Assessment
Change in cartilage appearance of the ipsilateral knee using MRI scanning
Secondary Outcome Measures
Change in Lysholm Knee Score
Change in Lysholm Knee Score (Scored 0-100, higher scores are better)
Change in Tegner Activity Scale
Change in Tegner Activity Scale (Scored 0-10, higher scores are move active)
Change in EQ-5D-5L
Change in EQ-5D-5L (EuroQol 5 Dimension 5 Level) (Each domain scored 1-5, lower scores are better)
Full Information
NCT ID
NCT04831671
First Posted
March 26, 2021
Last Updated
May 11, 2022
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04831671
Brief Title
MRI Assessment of Cartilage Damage in Tibial Nailing
Official Title
A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fractures of the tibia (shin bone) are frequently treated with a metal nail that is passed down the inside of the bone (an intra-medullary nail). This nail is inserted through the top of the tibia at the level of the knee joint. There are two ways for the nail to be inserted - either through an incision below the patella (kneecap) or above the patella.
The benefit of the incision above the patella is that it can make it technically easier to insert the nail into the correct position. However, the perceived risk of damage to the knee cartilage has prevented this technique from being widely adopted.
The investigators will use MRI scanning to assess the cartilage for damage using both techniques. The results will enable the investigators to determine if the theoretical risk of cartilage damage is found in real-world scenarios and to generate data for further, larger studies.
Detailed Description
Intra-medullary nailing is a common form of treatment for a variety of tibial shaft fractures. Traditionally this has been done via an infra-patella approach. More recently the use of a supra-patella approach has become more popular. However, there are concerns that the supra-patella approach may cause unacceptable damage to the cartilage of the patello-femoral joint (PFJ).
This study will use a novel MRI technique developed at the University of Cambridge to compare the amount of damage caused to the knee joint by both infra- and supra-patella nailing techniques. Specific cartilage assessment sequences will enable a fuller assessment of cartilage damage than can be achieved with normal structural sequences. Participants will also be asked to complete Patient Reported Outcome Measures (PROMs) regarding their injury to assess their clinical outcome.
Infra-patella and supra-patella nailing techniques are now both routine methods of carrying out intra-medullary nailing of the tibia. Further evidence is required, however, in order to fully assess whether one method is superior to the other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
MRI, Cartilage Damage, Surgical Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
It is not possible to mask participants or investigators as the surgical interventions in each arm will have different scars, making blinding impossible.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infra-patella nailing
Arm Type
Active Comparator
Arm Description
Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach.
Arm Title
Supra-patella nailing
Arm Type
Experimental
Arm Description
Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach.
Intervention Type
Other
Intervention Name(s)
Surgical Approach - Infra-patella nailing
Intervention Description
The intra-medullary nail will be introduced via an infra-patella incision.
Intervention Type
Other
Intervention Name(s)
Surgical Approach - Supra-patella nailing
Intervention Description
The intra-medullary nail will be introduced via a supra-patella incision.
Primary Outcome Measure Information:
Title
Change in cartilage appearance by MRI Assessment
Description
Change in cartilage appearance of the ipsilateral knee using MRI scanning
Time Frame
Pre-intervention, Day 1 post operatively, 6 months
Secondary Outcome Measure Information:
Title
Change in Lysholm Knee Score
Description
Change in Lysholm Knee Score (Scored 0-100, higher scores are better)
Time Frame
Pre-intervention, 6 weeks, 12 weeks, 6 months
Title
Change in Tegner Activity Scale
Description
Change in Tegner Activity Scale (Scored 0-10, higher scores are move active)
Time Frame
Pre-intervention, 6 weeks, 12 weeks, 6 months
Title
Change in EQ-5D-5L
Description
Change in EQ-5D-5L (EuroQol 5 Dimension 5 Level) (Each domain scored 1-5, lower scores are better)
Time Frame
Pre-interventional , 6 weeks, 12 weeks, 6 months
Other Pre-specified Outcome Measures:
Title
Bony Union of Fracture
Description
Bony union will be assessed by plain radiograph
Time Frame
6 weeks
Title
Bony Union of Fracture
Description
Bony union will be assessed by plain radiograph
Time Frame
12 weeks
Title
Bony Union of Fracture
Description
Bony union will be assessed by plain radiograph
Time Frame
6 months
Title
Post-operative Complications
Description
Post operative complications will be recorded
Time Frame
up to 6 months
Title
Return to work/employment status
Description
Patient return to normal activity will be recorded
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Closed tibial shaft fracture suitable for intramedullary nailing
Able to consent
Able to undergo MRI scanning
Able to attend follow up for 6 months post operatively
Suitable for surgery
Exclusion Criteria:
Polytrauma
Ipsilateral acute ligamentous knee injury
A contra-indication to MRI scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Carrothers, FRCS (Tr & Orth)
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Assessment of Cartilage Damage in Tibial Nailing
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