MRI Assessment of Cartilage Damage in Tibial Nailing

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04831671
• Other study ID #: A095899
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tibial Fractures

Intervention

Other:
• Surgical Approach - Infra-patella nailing
The intra-medullary nail will be introduced via an infra-patella incision.
• Surgical Approach - Supra-patella nailing
The intra-medullary nail will be introduced via a supra-patella incision.

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bony Union of Fracture	Bony union will be assessed by plain radiograph	6 weeks
Other	Bony Union of Fracture	Bony union will be assessed by plain radiograph	12 weeks
Other	Bony Union of Fracture	Bony union will be assessed by plain radiograph	6 months
Other	Post-operative Complications	Post operative complications will be recorded	up to 6 months
Other	Return to work/employment status	Patient return to normal activity will be recorded	6 months
Primary	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	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
Secondary	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
Secondary	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