MRI Assessment of Cartilage Damage in Tibial Nailing

• ClinicalTrials.gov Identifier: NCT04831671
• Recruitment Status: Active, not recruiting
• First Posted: April 5, 2021
• Last Update Posted: September 16, 2021
• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Information provided by (Responsible Party): Mr Andrew Carrothers, Cambridge University Hospitals NHS Foundation Trust

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.

Condition or disease	Intervention/treatment	Phase
Tibial Fractures	Other: Surgical Approach - Infra-patella nailing; Other: Surgical Approach - Supra-patella nailing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention 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.
• Primary Purpose: Treatment
• Official Title: A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures
• Actual Study Start Date: September 8, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in cartilage appearance by MRI Assessment [ Time Frame: Pre-intervention, Day 1 post operatively, 6 months ]
   Change in cartilage appearance of the ipsilateral knee using MRI scanning

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Bony Union of Fracture [ Time Frame: 6 weeks ]
   Bony union will be assessed by plain radiograph
2. Bony Union of Fracture [ Time Frame: 12 weeks ]
   Bony union will be assessed by plain radiograph
3. Bony Union of Fracture [ Time Frame: 6 months ]
   Bony union will be assessed by plain radiograph
4. Post-operative Complications [ Time Frame: up to 6 months ]
   Post operative complications will be recorded
5. Return to work/employment status [ Time Frame: 6 months ]
   Patient return to normal activity will be recorded

Eligibility Criteria

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

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

Contacts and Locations

Locations

United Kingdom

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

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

More Information

• Responsible Party: Mr Andrew Carrothers, Consultant Trauma and Orthopaedic Surgeon, Cambridge University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04831671
• Other Study ID Numbers: A095899
• First Posted: April 5, 2021
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr Andrew Carrothers, Cambridge University Hospitals NHS Foundation Trust:

MRI; Cartilage Damage; Surgical Techniques

Additional relevant MeSH terms:

Tibial Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries