A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System

Christian Candrian

Status: Enrolling

Conditions: Femoral Fracture

Treatments: Procedure: Intramedullary nailing with ADAPT system; Procedure: Intramedullary nailing without ADAPT system

Study type: Interventional

Funder types: Other

Identifiers

NCT04494672

ORL-ORT-015

Details and patient eligibility

About

The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.

Full description

This study is a 2-arm randomized controlled trial comparing intramedullary nailing of proximal fracture of the femur (AO classified as 31 A1.3 , 31 A2.1, 31 A2.2 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3) performed with the ADAPT system (arm-A) and those performed without (arm-B).

The ADAPT system has been developed with the aim to reduce the rate of complications in intramedullary nailing and its usefulness has been previously explored only in two underpowered randomized controlled trials. Thanks to the possibility to track screw placement in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in order to minimize radiation exposure, surgical time, and rate of complications.

All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and randomly allocated (allocation ratio 1:1) to receive preoperatively:

• Intramedullary nailing with ADAPT system (arm-A)
• Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating the results will be blinded to the assigned group.

The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and radiation exposure time will be collected.

Fracture healing, and rate of complications (cut-through and cut out) will be evaluated during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip through the Oxford Hip score.

All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12 ± 1 months.

Every patient will be involved in the trial for 1 year. The expected time to complete the trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up

Enrollment: 96 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
• Patients aged 50-85 years old.
• Patients with a BMI >18 and <35.
• Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
• Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.

Exclusion criteria

• Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).
• Known or suspected non-compliance, drug or alcohol abuse.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Previous enrolment into the current study.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Intramedullary nailing with ADAPT system (arm-A)

Experimental group

Description:

A commercial product, namely ADAPT will be used as investigation product in arm-A

Treatment:

Procedure: Intramedullary nailing with ADAPT system

Intramedullary nailing without ADAPT system (arm-B)

Active Comparator group

Description:

No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B

Treatment:

Procedure: Intramedullary nailing without ADAPT system