Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831671
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2021-03-26
Brief Title:
MRI Assessment of Cartilage Damage in Tibial Nailing
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None