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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in France

Martinique1 site
  • CHU de Martinique

    Fort-de-France

Other trials in Martinique

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 groups in NCT03444779
Study groupRoleWhat they receive
Control groupActive comparatorThe 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 groupExperimentalThe 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.

  1. 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)
  1. Knee range of motion (degrees)

    Knee range of motion

    Measured: Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24

  2. 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

  3. 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

  4. 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

  5. Description of Adverse events

    Adverse events

    Measured: from Inclusion to Month 24 (End Of Study)

  6. 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.

  1. First posted23 Feb 2018
  2. Study start26 Oct 2018
  3. Primary completion26 Oct 2022
  4. Study completion14 Nov 2024

Resources

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)
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

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.

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