MRI Assessment of Cartilage Damage in Tibial Nailing

Status Enrolling by invitation

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.

Clinical Trial 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

Related Conditions & MeSH terms

Tibial Fractures

Clinical Trial Details

NCT number	NCT04831671
Study type	Interventional
Source	Cambridge University Hospitals NHS Foundation Trust
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	April 1, 2022
Completion date	October 2023

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01132508` - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures	N/A
Terminated	`NCT00667849` - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures	N/A
Completed	`NCT00512434` - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture	N/A
Completed	`NCT00161616` - Study Evaluating InductOs in Diaphyseal Tibia Fractures	Phase 4
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Recruiting	`NCT03232216` - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.