MRI Assessment of Cartilage Damage in Tibial Nailing
- Conditions
- Tibial Fractures
- Interventions
- Other: Surgical Approach - Infra-patella nailingOther: Surgical Approach - Supra-patella nailing
- Registration Number
- NCT04831671
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- Polytrauma
- Ipsilateral acute ligamentous knee injury
- A contra-indication to MRI scanning
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infra-patella nailing Surgical Approach - Infra-patella nailing Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach. Supra-patella nailing Surgical Approach - Supra-patella nailing Participants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach.
- Primary Outcome Measures
Name Time Method Change in cartilage appearance by MRI Assessment Pre-intervention, Day 1 post operatively, 6 months Change in cartilage appearance of the ipsilateral knee using MRI scanning
- Secondary Outcome Measures
Name Time Method Change in EQ-5D-5L 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)
Change in Lysholm Knee Score Pre-intervention, 6 weeks, 12 weeks, 6 months Change in Lysholm Knee Score (Scored 0-100, higher scores are better)
Change in Tegner Activity Scale Pre-intervention, 6 weeks, 12 weeks, 6 months Change in Tegner Activity Scale (Scored 0-10, higher scores are move active)
Trial Locations
- Locations (1)
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom