Performance and Safety of the Innofix® Screw (IF25)

N/ANot Yet RecruitingNCT06800417

Innoprod Medical34 enrolled

Overview

The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) / Technical performances (Percutaneous implantation by mini-invasive approach, Efficiency of percutaneous implementation and efficiency of percuatneous cementing) / Safety performances (Preservation of the screw stability after implantation and preservation of the screw integrity after implantation). The safety and performance data about the InnoFix® screw will be used to obtain their CE marking according to the regulation (EU) 2017/745. The principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pathologic Fracture

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is 18 years old or more * The patient is a cancer patient * The patient needs a stabilization of a non-displaced pathologic fracture (complete or impending) of the pelvic bone * The patient is symptomatic with musculoskeletal pain exacerbated during movement or weight bearing * The patient has been informed and he has signed the informed consent * The patient must be willing and able to comply with all study requirements including follow-up visits and radiographic assessments * The patient is affiliated with the French social security system Exclusion Criteria: * The patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation * The patient is a pregnant woman or considered getting pregnant during its investigation participation * The patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator) * The patient has got one or more contraindications to general anaesthesia * The patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation * The use of the InnoFix® screw can interfere with anatomical structures or physiological performances * The patient has got an insufficient tissue coverage at the surgical site * The patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site * The patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications * The patient is allergic and/or hypersensitive to a component of the InnoFix® modules, of the InnoTool™ instruments and to the used cement * The patient has got a haemostasis disorder ((INR \>1.5, platelets \<50x109/L) * The patient participates to another clinical investigation * The patient's life expectancy is lower than 6 months * The patient is under guardianship, curatorship or legal protection * The patient is deprived of liberty by a judicial or administrative decision

Outcomes

Primary Outcomes

Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30%

Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain

Time frame: From the patient inclusion date to 6 weeks postoperatively

Secondary Outcomes

Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30%

The pain is measured with the VAS scale: Zero is equivalent to no pain and 10 indicates the worst possible pain

Time frame: From the patient inclusion date to 6 months postoperatively

Rate of postoperative stable fractures

Fracture stability is assessed with medical imaging: Length of fracture line in millieter (complete fracture) or fracture occurernce (impending fracture)

Time frame: From end surgery to 6 weeks and 6 months postoperatively

Rate of patients which have a mobility improvement rate postoperatively

Mobility is measured with ECOG scale:

Time frame: From the patient inclusion date to 6 weeks and 6 months postoperatively

Implantation success rate of the InnoFix® screw

Implantation succes is measured with medical imaging: Screw position compared to the fracture line and distance, in millimeters, of the distal tip of screw compared to the planned area and protrusion, in millimeters, of the proximal part of screw from the external cortex

Time frame: At the end of surgery

Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation

Efficiency of percutaneous implementation is based on the experiency of the radaiologist

Time frame: At the end of surgery

Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing

Efficiency of percutaneous cementing is based on the experiency of the radaiologist

Time frame: At the end of surgery

Rate of stable InnoFix® screws postoperatively

Screw stability is measured with medical imaging: Screw displacement in millimeters and contact with anatomical structures or other implanted devices

Time frame: From end surgery to 6 weeks and 6 months postoperatively

Rate of InnoFix® screws with their integrity preserved postoperatively

Screw integrity is measured with medical imaging: Disassembly, breakage or bending in millimeters

Time frame: From end surgery to 6 weeks and 6 months postoperatively

Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively

Adverse event reported

Time frame: From the patient inclusion date to 6 months postoperatively

Rate of patient which have had, at least, one serious adverse event in relation with the InnoFix® screw postoperatively

Serious adverse event reported

Time frame: From the patient inclusion date to 6 months postoperatively

Performance and Safety of the Innofix® Screw (IF25)

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts