PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System

NCT05351112 | Recruiting

• 1 other identifier: MDRG2017-89MS-44E
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Conditions

Proximal Humerus Fracture; Posttraumatic Arthrosis After Humeral Head Fracture; Posttraumatic Necrosis of the Humeral Head

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Safety; Clinical Benefits

Outcome Measures

Primary Outcomes (1)

• Incidence and frequency of revisions [Product safety based on implant survivorship]

  Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.

  3-10 years

Secondary Outcomes (4)

• Constant and Murley Score

  3-10 years

• Oxford Shoulder Score

  3-10 years

• EuroQol Five Dimensions Questionnaire

  3-10 years

• X-rays

  3-10 years

Study Arms (1)

Patients who received the Anatomical Shoulder 2.0 Fracture

Anatomical Shoulder 2.0 Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder 2.0 Fracture System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Patients 18 years or older and skeletally mature
• Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
• Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
• Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
• Posttraumatic necrosis of the humeral head
• Posttraumatic arthrosis after humeral head fracture

You may not qualify if:

• Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
• The patient is known to be pregnant or breastfeeding
• Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
• Patients with plans to relocate during the study follow-up period
• Signs of infection
• Extensive stiffening of the shoulder joint without pain

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Salamenca University Hospital

Salamanca, 37007, Spain

RECRUITING

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Julie Nicoux

CONTACT

+33 06 72 61 35 02; julie.nicoux@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: April 28, 2022
• Study Start: July 7, 2022
• Primary Completion (Estimated): January 21, 2034
• Study Completion (Estimated): January 21, 2034
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

ES (1)