Clinical trial NCT04831671: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tibial Fractures
Keywords: MRI
Cartilage Damage
Surgical Techniques
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in cartilage appearance by MRI Assessment
timeFrame: Pre-intervention, Day 1 post operatively, 6 months
Secondary outcomes:
measure: Change in Lysholm Knee Score
timeFrame: Pre-intervention, 6 weeks, 12 weeks, 6 months
measure: Change in Tegner Activity Scale
timeFrame: Pre-intervention, 6 weeks, 12 weeks, 6 months
measure: Change in EQ-5D-5L
timeFrame: Pre-interventional , 6 weeks, 12 weeks, 6 months
Other outcomes:
measure: Bony Union of Fracture
timeFrame: 6 weeks
measure: Bony Union of Fracture
timeFrame: 12 weeks
measure: Bony Union of Fracture
timeFrame: 6 months
measure: Post-operative Complications
timeFrame: up to 6 months
measure: Return to work/employment status
timeFrame: 6 months
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Andrew Carrothers, FRCS (Tr & Orth)
role: PRINCIPAL_INVESTIGATOR
References: