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

NCT04494672 | Recruiting

• 1 other identifier: ORL-ORT-015
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• time of the procedure

  immediately after the surgery

• intraoperative blood loss

  during the surgery

• intraoperative radiation time

  during the surgery

• surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)

  immediately after the surgery

• non-union

  at 6 weeks, 3 months, 6 months and 1-year

Other Outcomes (1)

• re-fracture rates

  at 6 weeks, 3 months, 6 months and 1-year

Study Arms (2)

Intramedullary nailing with ADAPT system (arm-A)

EXPERIMENTAL

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

Procedure: Intramedullary nailing with ADAPT system

Intramedullary nailing without ADAPT system (arm-B)

ACTIVE COMPARATOR

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

Procedure: Intramedullary nailing without ADAPT system

Interventions

Intramedullary nailing with ADAPT system PROCEDURE

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

Intramedullary nailing with ADAPT system (arm-A)

Intramedullary nailing without ADAPT system PROCEDURE

Intramedullary nailing without ADAPT system

Intramedullary nailing without ADAPT system (arm-B)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Candrian: lead

Study Sites (1)

Christian Candrian

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Christian Candrian, MD

  Ente Ospedaliero Cantonale, Bellinzona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Candrian, MD

CONTACT

0041918117029; RicercaOrtopedia.ORL@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Med.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 31, 2020
• Study Start: September 28, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)