Assessment of the Surgical Handling and Performance of the X-ray-based Tracking and Navigation System "Xin1 Humerus System" Evaluated From 10 Proximal Humerus Plate Fixations

NCT03427112 | Completed FDA Device

• 2 other identifiers: Xin1Humerus80M0661
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. The aim is to validate the system performance in a clinical context and test the surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a proximal humerus fracture and are indicated for plate fixation osteosynthesis will be provided intraoperatively with the Xin1 marker. The system performance is evaluated retrospectively by post-processing the intraoperative X-ray images after surgery

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (1)

• Influence of plate fixation on the determined screw lengths derived from the Xin1 Humerus System

  Xin1 Humerus System: * Screw lengths determined after fracture reduction and temporary fixation * Screw lengths determined after final plate fixation

  during surgery

Secondary Outcomes (3)

• Treatment information

  during surgery

• Patient information

  Preoperative

• System information

  during surgery

Interventions

Xin1 Humerus System DEVICE

Retrospective assessment of the surgical handling and performance of the X-ray-based tracking and navigation system "Xin1 Humerus system" evaluated from 10 proximal humerus plate fixations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proximal humerus fracture which are transferred to the Dpt. Traumatologie, ZU Leuven, will be recruited during diagnosis and indication.

You may qualify if:

• Age 18 years and older
• Diagnosis of proximal humerus fracture
• Indicated for plate fixation osteosynthesis
• Informed consent obtained

Sponsors & Collaborators

• AO Research Institute Davos: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (2)

• Voigt C, Woltmann A, Partenheimer A, Lill H. [Management of complications after angularly stable locking proximal humerus plate fixation]. Chirurg. 2007 Jan;78(1):40-6. doi: 10.1007/s00104-006-1241-0. German.

  PMID: 16998660 BACKGROUND

• Solberg BD, Moon CN, Franco DP, Paiement GD. Locked plating of 3- and 4-part proximal humerus fractures in older patients: the effect of initial fracture pattern on outcome. J Orthop Trauma. 2009 Feb;23(2):113-9. doi: 10.1097/BOT.0b013e31819344bf.

  PMID: 19169103 BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Stefaan Nijs, Prof.

  UZ Leuven campus Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 9, 2018
• Study Start: April 4, 2017
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)