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

Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Fracture
• Intervention / Treatment: Procedure: Intramedullary nailing with ADAPT system; Procedure: Intramedullary nailing without ADAPT system

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

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Candrian, MD; Phone Number: 0041918117029; Email: RicercaOrtopedia.ORL@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Christian Candrian
    • Contact: Christian Candrian, Prof.Dr.med; Phone Number: +41 (0) 91 811 61 23; Email: christian.candrian@eoc.ch
    • Contact: Gianluigi Capone, Dr.; Email: gianluigi.capone@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intramedullary nailing with ADAPT system (arm-A); A commercial product, namely ADAPT will be used as investigation product in arm-A	Procedure: Intramedullary nailing with ADAPT system; Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH & Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively
Active Comparator: Intramedullary nailing without ADAPT system (arm-B); No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B	Procedure: Intramedullary nailing without ADAPT system; Intramedullary nailing without ADAPT system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAD (tip to apex) index at the post-operative X-Ray control prior discharge	The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge. The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.	immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of the procedure	time	immediately after the surgery
intraoperative blood loss	intraoperative blood loss	during the surgery
intraoperative radiation time	intraoperative radiation time	during the surgery
surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)	The satisfaction NRS is a self-assessment scale in which surgeons rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery	immediately after the surgery
non-union	fracture not alligned	at 6 weeks, 3 months, 6 months and 1-year
cut-through rate	cut-through rate	at 6 weeks, 3 months, 6 months and 1-year
cut-out rate	cut-out rate	at 6 weeks, 3 months, 6 months and 1-year
VAS	Visual pain analogue scale, [from 0 (no pain) to 10 (worst pain)]	at 6 weeks, 3 months, 6 months and 1-year
Oxford Hip Score, [from 0 (severe hip arthritis) to 48 ( satisfactory joint function)]	Hip function	at 6 weeks, 3 months, 6 months and 1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-fracture rates	re-fracture rates	at 6 weeks, 3 months, 6 months and 1-year

Collaborators and Investigators

• Sponsor: Christian Candrian
• Investigators: Principal Investigator: Christian Candrian, MD, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: ORL-ORT-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not foreseen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No