Clinical trial NCT04494672: A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System
Official title: Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Fracture
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: TAD (tip to apex) index at the post-operative X-Ray control prior discharge
timeFrame: immediately after the surgery
Secondary outcomes:
measure: time of the procedure
timeFrame: immediately after the surgery
measure: intraoperative blood loss
timeFrame: during the surgery
measure: intraoperative radiation time
timeFrame: during the surgery
measure: surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
timeFrame: immediately after the surgery
measure: non-union
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
measure: cut-through rate
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
measure: cut-out rate
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
measure: VAS
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
measure: Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
Other outcomes:
measure: re-fracture rates
timeFrame: at 6 weeks, 3 months, 6 months and 1-year
Locations:
city: Lugano
country: Switzerland
facility: Christian Candrian
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Christian Candrian, MD
role: PRINCIPAL_INVESTIGATOR
References: