MRI Assessment of Cartilage Damage in Tibial Nailing

A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tibial Fractures
• Intervention / Treatment: Other: Surgical Approach - Infra-patella nailing; Other: Surgical Approach - Supra-patella nailing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infra-patella nailing; Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach.	Other: Surgical Approach - Infra-patella nailing; The intra-medullary nail will be introduced via an infra-patella incision.
Experimental: Supra-patella nailing; Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach.	Other: Surgical Approach - Supra-patella nailing; The intra-medullary nail will be introduced via a supra-patella incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cartilage appearance by MRI Assessment	Change in cartilage appearance of the ipsilateral knee using MRI scanning	Pre-intervention, Day 1 post operatively, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lysholm Knee Score	Change in Lysholm Knee Score (Scored 0-100, higher scores are better)	Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in Tegner Activity Scale	Change in Tegner Activity Scale (Scored 0-10, higher scores are move active)	Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in EQ-5D-5L	Change in EQ-5D-5L (EuroQol 5 Dimension 5 Level) (Each domain scored 1-5, lower scores are better)	Pre-interventional , 6 weeks, 12 weeks, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bony Union of Fracture	Bony union will be assessed by plain radiograph	6 weeks
Bony Union of Fracture	Bony union will be assessed by plain radiograph	12 weeks
Bony Union of Fracture	Bony union will be assessed by plain radiograph	6 months
Post-operative Complications	Post operative complications will be recorded	up to 6 months
Return to work/employment status	Patient return to normal activity will be recorded	6 months

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Andrew Carrothers, FRCS (Tr & Orth), Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Cartilage Damage; Surgical Techniques
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Tibial Fractures
• Other Study ID Numbers: A095899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No