Schatzker Type 2 or 3 Tibial Plateau FractureTUBERIMPACTNCT03444779
Comparative Evaluation of Minimally Invasive "tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures
A study testing Tibial Tuberoplasty and Open technique in people with Schatzker Type 2 or 3 Tibial Plateau Fracture, run by Poitiers University Hospital at 12 sites in 2 countries.
Trial summary
PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schatzker Type 2 or 3 Tibial Plateau Fracture
- What is being tested?
- Tibial Tuberoplasty and Open technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 26 Oct 2018to 14 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Patients with a Schatzker type 2 or 3 tibial plateau fracture (compression with or without split) demonstrated on CT-scan and located in the lateral or medial condyle of tibia.
- Patients with fractures caused by trauma.
- Patients with fractures 10 days old maximum.
- Understand and accept the constraints of the study.
- Be a beneficiary or affiliated member of a Health Insurance plan.
- Give written consent for the study after having received clear information.
Who cannot join
- Age < 18 years old.
- Patients with fractures resulting from osteolysis.
- Patients with open fractures.
- Patients with fractures more than 10 days old.
- Patients with concomitant fracture(s) or condition(s) during the trauma reducing the range of motion.
- Patients unable to walk before the injury.
Show all 13Show fewer
- History of sepsis in the injured knee.
- Contraindications to anesthesia, contrast agent, medical devices or cement.
- History of hypersensitivity reactions to contrast media, bone filler or metal.
- Patients with a degenerative joint disease (polyarthritis, etc.).
- Absence of signature of the informed consent form.
- Patients not covered by French national health insurance.
- Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France11 sites
CHU d'Amiens
Amiens
CHU Angers
Angers
AP-HP / Hopital Ambroise Paré
Boulogne-Billancourt
CHU de Brest
Brest
CHU Dijon
Dijon
CHU de Nantes
Nantes
CHU de Poitiers
Poitiers
CHU de Rennes
Rennes
CHU Rouen
Rouen
CHRU Tours
Tours
CH Versailles
Versailles
About this study
Official title: Comparative Evaluation of Minimally Invasive "tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures (TUBERIMPACT Study)
PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in France. 50% of these surgical fractures is related to the lateral condyle and causes split/depression (Schatzker 2) or pure depression (Schatzker 3). This high rate results from the recent democratization of high-risk sports, as well as an aging population with increased risks of falling. Aside from the resulting reduced physical activity, the social and professional impact of these fractures is undeniable and represents significant costs for our health care system. A recently published prospective case series reports 28 job losses out of 41 patients treated.
The clinical outcome of these patients depends mainly on the primary stability provided by the surgical treatment, after the greatest anatomical reduction possible. Indeed, Giannoudis and al. have demonstrated that under simple X-rays, the smaller the detected step-off, the better the outcome.The aim is to allow for recovery of good joint mobility to promote rapid resumption of activity and to limit the onset of early osteoarthritis.
Read more
The classical technique used for reduction and osteosynthesis of tibial plateau fractures (open surgical technique using a bone tamp) has several pitfalls : devascularization of the bone and skin, risks of infection and functional rehabilitation difficulties with delayed recovery of weight bearing. Moreover, this technique does not allow for the simultaneous diagnosis and treatment of other possible lesions, such as meniscal injuries in particular.
Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive technique for the reduction and stabilization of tibial plateau fractures, baptized "Tibial Tuberoplasty". The concept derives from the divergent use of vertebral kyphoplasty, initially dedicated for spinal injuries and transposed here to the tibial plateau. This technique involves expansion of the tibial plateau through inflation of a kyphoplasty balloon, filling of the created cavity with cement (PMMA, calcium phosphate) and percutaneous screw fixation.
Orthopaedic surgeons of Poitiers University Hospital performed the first tibial tuberoplasties through a feasibility study on 36 cadaveric subjects and then transposed the technique to human. Surgeons identified major advantages such as minimal skin damage, possible treatment of posterior and multi-fragmented compressions (lifting in a single block by the balloon), reinforcement of the stability of the assembly using cement, possible use of combined arthroscopy (for concomitant meniscal injuries treatment).
This technique allows for optimization of the fracture reduction by elevating the posterior fragments with the inflatable bone tamp through an anterior approach. The reduction is made possible thanks to the specificity of the inflatable bone tamp which inflates and reduces the area of least resistance.
The aim of this innovative technique is focused on the anatomical reduction in order to restore the convexity of the tibial plateau which is similar to the balloon convexity.
The results from the first 40 patients operated since 2011 are promising and show a proportion of 70% presenting less than 5 mm step-off reduction. A larger scale multicenter randomized controlled trial is now requested to further demonstrate the superiority of the "Tibial Tuberoplasty" to the standard treatment.
The coordinator investigator designed this study to evaluate the quality of tibial fracture reduction offered by percutaneous "Tibial Tuberoplasty" versus conventional open surgery for tibial plateau fracture but also its impact on clinical outcome.
- Being tested
- Tibial Tuberoplasty, Open technique
- Keywords
- tibial plateau fracture, minimally invasive surgery, ballon reduction
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial TuberoplastyDevice
Kyphoplasty ballon
Open techniqueDevice
Cutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients will be treated with an open technique: cutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope. The reduction will be performed using a spatula, a bone tamp or open reduction internal fixation. The osteosynthesis and filling of the cavity will be performed by the same surgical access. Receives: Device: Open technique |
| Experimental group | Experimental | The patients will be treated with the "Tibial Tuberoplasty" technique under fluoroscopic guidance with or without arthroscopy. The reduction will be performed by an anterior approach using a kyphoplasty balloon. The combined osteosynthesis including cannulated screws and cementoplasty will both be performed by a percutaneous technique. Receives: Device: Tibial Tuberoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative radiological step-off reduction blindly measured by high resolution CT-scan
Compare step-off anatomical reduction of tibial plateau fracture by "Tibial Tuberoplasty" versus conventional open surgery using CT-scan
Measured: Day 2
Secondary outcomes (6)
Knee range of motion (degrees)
Knee range of motion
Measured: Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Numeric Pain Rating Scale
The NPRS is an 11-point scale from 0-10 ("0" = no pain and "10" = the most intense pain imaginable). Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.
Measured: Inclusion, Day 2, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Knee injury and Osteoarthritis Outcome Score
The KOOS questionnaire is a functional score validated in the French language and one of the only validated in knee trauma. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The KOOS has been validated for several orthopaedic interventions such as anterior cruciate ligament reconstruction, meniscectomy and total knee replacement.
Measured: Inclusion, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Score on Euro Quality of Life-5 Dimension Health questionnaire
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life (HRQoL) which comprises a descriptive system and a visual analogue scale. The descriptive system is composed of 5 questions assessing mobility, self-care, usual activities, pain/discomfort and anxiety/depression with 5 possible responses for each item: 1- no problems, 2- slight problems, 3- moderate problems, 4- severe problems and 5- extreme problems). A global index with a maximum score of 1 is calculated from the responses to these 5 dimensions by means of normograms. The maximum score of 1 indicates the best possible quality of life. The visual analogue scale ranging from 0 to 100 also allows the patient to rate his/her perceived quality of life, where 100 indicates the best possible quality of life.
Measured: Inclusion, Day 45, Month 3, Month 6, Month 12 and Month 24
Description of Adverse events
Adverse events
Measured: from Inclusion to Month 24 (End Of Study)
Time to partial and full weight-bearing
Time to partial and full weight-bearing
Measured: from Day 0 (surgery) to Month 24 (End Of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start26 Oct 2018
- Primary completion26 Oct 2022
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schatzker Type 2 or 3 Tibial Plateau FractureStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanguy VENDEUVRE, Dr, Principal investigator, Poitiers Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444779
- Sponsor's protocol ID
- 2018-A01027-48
- Acronym
- TUBERIMPACT
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2018
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vendeuvre T, Monlezun O, Brandet C, Ingrand P, Durand-Zaleski I, Gayet LE, Germaneau A, Khiami F, Roulaud M, Herpe G, Rigoard P. Comparative evaluation of minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery for Schatzker II-III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study). BMJ Open. 2019 Sep 3;9(8):e026962. doi: 10.1136/bmjopen-2018-026962.
PubMed 31481365
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Minimally Invasive "tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures (TUBERIMPACT Study)
- ClinicalTrials.gov ID
- NCT03444779
- Acronym / sponsor ID
- TUBERIMPACT / 2018-A01027-48
- Keywords
- tibial plateau fracture, minimally invasive surgery, ballon reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 23 Feb 2018 (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.
PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in France. 50% of these surgical fractures is related to the lateral condyle and causes split/depression (Schatzker 2) or pure depression (Schatzker 3). This high rate results from the recent democratization of high-risk sports, as well as an aging population with increased risks of falling. Aside from the resulting reduced physical activity, the social and professional impact of these fractures is undeniable and represents significant costs for our health care system. A recently published prospective case series reports 28 job losses out of 41 patients treated.
The clinical outcome of these patients depends mainly on the primary stability provided by the surgical treatment, after the greatest anatomical reduction possible. Indeed, Giannoudis and al. have demonstrated that under simple X-rays, the smaller the detected step-off, the better the outcome.The aim is to allow for recovery of good joint mobility to promote rapid resumption of activity and to limit the onset of early osteoarthritis.
The classical technique used for reduction and osteosynthesis of tibial plateau fractures (open surgical technique using a bone tamp) has several pitfalls : devascularization of the bone and skin, risks of infection and functional rehabilitation difficulties with delayed recovery of weight bearing. Moreover, this technique does not allow for the simultaneous diagnosis and treatment of other possible lesions, such as meniscal injuries in particular.
Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive technique for the reduction and stabilization of tibial plateau fractures, baptized "Tibial Tuberoplasty". The concept derives from the divergent use of vertebral kyphoplasty, initially dedicated for spinal injuries and transposed here to the tibial plateau. This technique involves expansion of the tibial plateau through inflation of a kyphoplasty balloon, filling of the created cavity with cement (PMMA, calcium phosphate) and percutaneous screw fixation.
Orthopaedic surgeons of Poitiers University Hospital performed the first tibial tuberoplasties through a feasibility study on 36 cadaveric subjects and then transposed the technique to human. Surgeons identified major advantages such as minimal skin damage, possible treatment of posterior and multi-fragmented compressions (lifting in a single block by the balloon), reinforcement of the stability of the assembly using cement, possible use of combined arthroscopy (for concomitant meniscal injuries treatment).
This technique allows for optimization of the fracture reduction by elevating the posterior fragments with the inflatable bone tamp through an anterior approach. The reduction is made possible thanks to the specificity of the inflatable bone tamp which inflates and reduces the area of least resistance.
The aim of this innovative technique is focused on the anatomical reduction in order to restore the convexity of the tibial plateau which is similar to the balloon convexity.
The results from the first 40 patients operated since 2011 are promising and show a proportion of 70% presenting less than 5 mm step-off reduction. A larger scale multicenter randomized controlled trial is now requested to further demonstrate the superiority of the "Tibial Tuberoplasty" to the standard treatment.
The coordinator investigator designed this study to evaluate the quality of tibial fracture reduction offered by percutaneous "Tibial Tuberoplasty" versus conventional open surgery for tibial plateau fracture but also its impact on clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Open techniqueThe patients will be treated with an open technique: cutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope. The reduction will be performed using a spatula, a bone tamp or open reduction internal fixation. The osteosynthesis and filling of the cavity will be performed by the same surgical access. |
| Experimental group | Experimental | Device: Tibial TuberoplastyThe patients will be treated with the "Tibial Tuberoplasty" technique under fluoroscopic guidance with or without arthroscopy. The reduction will be performed by an anterior approach using a kyphoplasty balloon. The combined osteosynthesis including cannulated screws and cementoplasty will both be performed by a percutaneous technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old.
- Patients with a Schatzker type 2 or 3 tibial plateau fracture (compression with or without split) demonstrated on CT-scan and located in the lateral or medial condyle of tibia.
- Patients with fractures caused by trauma.
- Patients with fractures 10 days old maximum.
- Understand and accept the constraints of the study.
Key exclusion criteria (13 listed)
- Age < 18 years old.
- Patients with fractures resulting from osteolysis.
- Patients with open fractures.
- Patients with fractures more than 10 days old.
- Patients with concomitant fracture(s) or condition(s) during the trauma reducing the range of motion.
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 |
|---|---|---|
| Tibial TuberoplastyKyphoplasty ballon | Device | Experimental group |
| Open techniqueCutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope. | Device | Control group |
Primary outcome
Post-operative radiological step-off reduction blindly measured by high resolution CT-scan
Time frame: Day 2
Compare step-off anatomical reduction of tibial plateau fracture by "Tibial Tuberoplasty" versus conventional open surgery using CT-scan
6 secondary outcomes
Knee range of motion (degrees)
Time frame: Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Numeric Pain Rating Scale
Time frame: Inclusion, Day 2, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Knee injury and Osteoarthritis Outcome Score
Time frame: Inclusion, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24
Score on Euro Quality of Life-5 Dimension Health questionnaire
Time frame: Inclusion, Day 45, Month 3, Month 6, Month 12 and Month 24
Description of Adverse events
Time frame: from Inclusion to Month 24 (End Of Study)
Time to partial and full weight-bearing
Time frame: from Day 0 (surgery) to Month 24 (End Of Study)
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 2 Dec 2024.
- Derived from this study: PubMed 31481365Vendeuvre T, Monlezun O, Brandet C, Ingrand P, Durand-Zaleski I, Gayet LE, Germaneau A, Khiami F, Roulaud M, Herpe G, Rigoard P. Comparative evaluation of minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery for Schatzker II-III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study). BMJ Open. 2019 Sep 3;9(8):e026962. doi: 10.1136/bmjopen-2018-026962.
- Individual participant dataSharing planned: No
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.
Tanguy VENDEUVRE, Dr principal investigator
Poitiers Hospital University
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial Tuberoplasty and Open technique in people with Schatzker Type 2 or 3 Tibial Plateau Fracture, run by Poitiers University Hospital at 12 sites in 2 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 7 inclusion and 13 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Martinique. 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?
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?
Post-operative radiological step-off reduction blindly measured by high resolution CT-scan (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444779, which also lists 1 linked publication.
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 2 Dec 2024.