MRI Assessment of Cartilage Damage in Tibial Nailing

NCT04831671 | Unknown DMC

• 1 other identifier: A095899
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fractures

Keywords

MRI; Cartilage Damage; Surgical Techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Lysholm Knee Score

  Pre-intervention, 6 weeks, 12 weeks, 6 months

• Change in Tegner Activity Scale

  Pre-intervention, 6 weeks, 12 weeks, 6 months

• Change in EQ-5D-5L

  Pre-interventional , 6 weeks, 12 weeks, 6 months

Other Outcomes (5)

• Bony Union of Fracture

  6 weeks

• Bony Union of Fracture

  12 weeks

• Bony Union of Fracture

  6 months

Study Arms (2)

Infra-patella nailing

ACTIVE COMPARATOR

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

Supra-patella nailing

EXPERIMENTAL

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

Interventions

Surgical Approach - Infra-patella nailing OTHER

The intra-medullary nail will be introduced via an infra-patella incision.

Infra-patella nailing

Surgical Approach - Supra-patella nailing OTHER

The intra-medullary nail will be introduced via a supra-patella incision.

Supra-patella nailing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Polytrauma
• Ipsilateral acute ligamentous knee injury
• A contra-indication to MRI scanning

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Andrew Carrothers, FRCS (Tr & Orth)

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask participants or investigators as the surgical interventions in each arm will have different scars, making blinding impossible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Trauma and Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)