Tibial FracturesNCT04831671
MRI Assessment of Cartilage Damage in Tibial Nailing
A study testing Surgical Approach - Infra-patella nailing and Surgical Approach - Supra-patella nailing in people with Tibial Fractures, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Surgical Approach - Infra-patella nailing and Surgical Approach - Supra-patella nailing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Polytrauma
- Ipsilateral acute ligamentous knee injury
- A contra-indication to MRI scanning
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures
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.
Read the 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.
- Conditions
- Tibial Fractures
- Being tested
- Surgical Approach - Infra-patella nailing, Surgical Approach - Supra-patella nailing
- Keywords
- MRI, Cartilage Damage, Surgical Techniques
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Approach - Infra-patella nailingOther
The intra-medullary nail will be introduced via an infra-patella incision.
Surgical Approach - Supra-patella nailingOther
The intra-medullary nail will be introduced via a supra-patella incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Surgical Approach - Supra-patella nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cartilage appearance by MRI Assessment
Change in cartilage appearance of the ipsilateral knee using MRI scanning
Measured: Pre-intervention, Day 1 post operatively, 6 months
Secondary outcomes (3)
Change in Lysholm Knee Score
Change in Lysholm Knee Score (Scored 0-100, higher scores are better)
Measured: Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in Tegner Activity Scale
Change in Tegner Activity Scale (Scored 0-10, higher scores are move active)
Measured: Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in EQ-5D-5L
Change in EQ-5D-5L (EuroQol 5 Dimension 5 Level) (Each domain scored 1-5, lower scores are better)
Measured: Pre-interventional , 6 weeks, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Andrew Carrothers, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Andrew Carrothers, FRCS (Tr & Orth), Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831671
- Sponsor's protocol ID
- A095899
- Status last verified
- May 2022
- First submitted
- 26 Mar 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Prospective Comparison of Two Approaches for Tibial Nailing Using Clinical and Novel Imaging Outcome Measures
- ClinicalTrials.gov ID
- NCT04831671
- Acronym / sponsor ID
- A095899
- Conditions
- Tibial Fractures
- Keywords
- MRI, Cartilage Damage, Surgical Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infra-patella nailing | Active comparator | Other: Surgical Approach - Infra-patella nailingParticipants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an infra-patella approach. |
| Supra-patella nailing | Experimental | Other: Surgical Approach - Supra-patella nailingParticipants will have their closed tibial shaft fracture treated with an intra-medullary nail inserted through an supra-patella approach. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Polytrauma
- Ipsilateral acute ligamentous knee injury
- A contra-indication to MRI scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Approach - Infra-patella nailingThe intra-medullary nail will be introduced via an infra-patella incision. | Other | Infra-patella nailing |
| Surgical Approach - Supra-patella nailingThe intra-medullary nail will be introduced via a supra-patella incision. | Other | Supra-patella nailing |
Primary outcome
Change in cartilage appearance by MRI Assessment
Time frame: Pre-intervention, Day 1 post operatively, 6 months
Change in cartilage appearance of the ipsilateral knee using MRI scanning
3 secondary outcomes
Change in Lysholm Knee Score
Time frame: Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in Tegner Activity Scale
Time frame: Pre-intervention, 6 weeks, 12 weeks, 6 months
Change in EQ-5D-5L
Time frame: Pre-interventional , 6 weeks, 12 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Carrothers, FRCS (Tr & Orth) principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Approach - Infra-patella nailing and Surgical Approach - Supra-patella nailing in people with Tibial Fractures, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cartilage appearance by MRI Assessment (time frame: Pre-intervention, Day 1 post operatively, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.