Tibial FracturesPhase 4TrigenMETANCT01358292
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
A Phase 4 study testing Semi-extended Surgical Technique and Standard Surgical Technique in people with Tibial Fractures, run by Smith & Nephew Orthopaedics AG at 5 sites in 3 countries.
Trial summary
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Semi-extended Surgical Technique and Standard Surgical Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2011to Oct 2015
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
- Patient has an isolated tibia and fibula fracture
- Skeletally mature
- Patients aged between/including 18 to 70 years
- Patient has given formal consent to be involved in the trial and has completed the study consent form
- Patient is likely to comply with study follow-up requirements
Who cannot join
- Pathologic fractures
- Other fractures involving the same lower extremity
- Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
- Patient having pre-existing knee joint disease causing anterior knee pain
- Patient likely to have problems with follow-up
- Patient unwilling to give informed consent to be included in the trial
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom2 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Nottingham University Hospitals
Nottingham, NG7 2UH
About this study
Official title: Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)
Research Objectives:
Read more
The primary research objectives are to evaluate:
- anterior knee pain and ii) the nail position and overall fracture alignment
Outcome Measures:
- Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
- Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
- Knee-related adverse events
- Overall fracture alignment
Read the detailed description
After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture.
Using the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.
- Conditions
- Tibial Fractures
- Being tested
- Semi-extended Surgical Technique, Standard Surgical Technique
- Keywords
- Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-extended Surgical TechniqueProcedure or surgery
Also called Trigen META Intramedullray Tibia Nail
Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
Standard Surgical TechniqueProcedure or surgery
Also called Trigen META intramedullary tibia nailing
Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.
| Study group | Role | What they receive |
|---|---|---|
| Semi-extended surgical technique | Experimental | The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion. Receives: Procedure: Semi-extended Surgical Technique |
| Standard Surgical Technique | Active comparator | The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion. Receives: Procedure: Standard Surgical Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Knee Pain
Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)
Measured: 4, 6 and 12 months post-operative
Secondary outcomes (1)
Nail positioning
Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail.
Measured: Operation (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2015
- Study completionOct 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Johnstone, Professor, Principal investigator, Aberdeen Royal InfirmaryPedro Caba, Dr., Study chair, Hospital de 12 Octubre, MadridMarkus Graf, Dr., Study chair, Medizinisches Zentrum StädteRegion AachenIsmael Escriba, Dr., Study chair, HOSPITAL LA FE VALENCIADaren Forward, MA, FRCS, DM, Study chair, Nottingham University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358292
- Sponsor's protocol ID
- R11021-1
- Acronym
- TrigenMETA
- Status last verified
- Nov 2015
- First submitted
- 14 Jan 2011
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01358292
- Acronym / sponsor ID
- TrigenMETA / R11021-1
- Conditions
- Tibial Fractures
- Keywords
- Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 May 2011 (estimated)
- 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.
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)
Research Objectives:
The primary research objectives are to evaluate:
- anterior knee pain and ii) the nail position and overall fracture alignment
Outcome Measures:
- Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
- Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
- Knee-related adverse events
- Overall fracture alignment
Detailed description
After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture.
Using the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-extended surgical technique | Experimental | Procedure: Semi-extended Surgical TechniqueThe experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion. |
| Standard Surgical Technique | Active comparator | Procedure: Standard Surgical TechniqueThe standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
- Patient has an isolated tibia and fibula fracture
- Skeletally mature
- Patients aged between/including 18 to 70 years
- Patient has given formal consent to be involved in the trial and has completed the study consent form
Key exclusion criteria (6 listed)
- Pathologic fractures
- Other fractures involving the same lower extremity
- Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
- Patient having pre-existing knee joint disease causing anterior knee pain
- Patient likely to have problems with follow-up
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 |
|---|---|---|
| Semi-extended Surgical TechniqueAlso: Trigen META Intramedullray Tibia NailSurgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail. | Procedure or surgery | Semi-extended surgical technique |
| Standard Surgical TechniqueAlso: Trigen META intramedullary tibia nailingTh e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion. | Procedure or surgery | Standard Surgical Technique |
Primary outcome
Anterior Knee Pain
Time frame: 4, 6 and 12 months post-operative
Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)
1 secondary outcome
Nail positioning
Time frame: Operation (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- 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.
Alan Johnstone, Professor principal investigator
Aberdeen Royal Infirmary
Pedro Caba, Dr. study chair
Hospital de 12 Octubre, Madrid
Markus Graf, Dr. study chair
Medizinisches Zentrum StädteRegion Aachen
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semi-extended Surgical Technique and Standard Surgical Technique in people with Tibial Fractures, run by Smith & Nephew Orthopaedics AG at 5 sites in 3 countries.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United Kingdom, Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anterior Knee Pain (time frame: 4, 6 and 12 months post-operative). 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 17 Jun 2016.