Clinical trial NCT05351112: PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Detailed description: The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoulder arthroplasty. The system is intended for long-term implantation into the human shoulder joint to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

Two sites will be involved in this study. The aim is to include a total of 78 consecutive series cases who received the Anatomical Shoulder 2.0 Fracture starting from 2014. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
  2. Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
  3. Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
  4. Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
  5. Posttraumatic necrosis of the humeral head
  6. Posttraumatic arthrosis after humeral head fracture

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence and frequency of revisions [Product safety based on implant survivorship]
timeFrame: 3-10 years
Secondary outcomes:
measure: Constant and Murley Score
timeFrame: 3-10 years
measure: Oxford Shoulder Score
timeFrame: 3-10 years
measure: EuroQol Five Dimensions Questionnaire
timeFrame: 3-10 years
measure: X-rays
timeFrame: 3-10 years
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Salamenca University Hospital
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: