Comparative Evaluation of Minimally Invasive "tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures

NCT03444779 | Completed

• 1 other identifier: 2018-A01027-48
• Study Type: interventional
• Target: 137
• Locations: 2 countries
• Sites: 12

Brief 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. 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.

Conditions

Schatzker Type 2 or 3 Tibial Plateau Fracture

Keywords

tibial plateau fracture; minimally invasive surgery; ballon reduction

Outcome Measures

Primary Outcomes (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

  Day 2

Secondary Outcomes (6)

• Knee range of motion (degrees)

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

• Numeric Pain Rating Scale

  Inclusion, Day 2, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24

• Knee injury and Osteoarthritis Outcome Score

  Inclusion, Day 21, Day 45, Month 3, Month 6, Month 12 and Month 24

• Score on Euro Quality of Life-5 Dimension Health questionnaire

  Inclusion, Day 45, Month 3, Month 6, Month 12 and Month 24

• Description of Adverse events

  from Inclusion to Month 24 (End Of Study)

Study Arms (2)

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.

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.

Device: Tibial Tuberoplasty

Interventions

Tibial Tuberoplasty DEVICE

Kyphoplasty ballon

Experimental group

Open technique DEVICE

Cutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (12)

CHU d'Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

AP-HP / Hopital Ambroise Paré

Boulogne-Billancourt, France

Location

CHU de Brest

Brest, France

Location

CHU Dijon

Dijon, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHRU Tours

Tours, France

Location

CH Versailles

Versailles, France

Location

CHU de Martinique

Fort-de-France, Martinique

Location

Related Publications (1)

• 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.

  PMID: 31481365 DERIVED

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Open Abdomen Techniques

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Abdominal Wound Closure Techniques; Wound Closure Techniques; Surgical Procedures, Operative

Study Officials

• Tanguy VENDEUVRE, Dr

  Poitiers Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient blinded until D2 visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 23, 2018
• Study Start: October 26, 2018
• Primary Completion: October 26, 2022
• Study Completion: November 14, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11); MA (1)