Clinical trial NCT05773352: Perform® Humeral System - Fracture Study (PFX)
Official title: Tornier Perform® Humeral System - Fracture Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Traumatic Arthropathy of Shoulder
Fracture Humerus
Traumatic Arthritis
Revision of Other Devices if Sufficient Bone Stock Remains
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 120 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reverse shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.

Brief summary: This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.

Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.

Detailed description: This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations.

The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse).

Retrospective inclusions are allowed: preoperative, intra operative, and 6 months data can be collected retrospectively up to 12 months after the surgery date.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification.

Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study.

Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively.

Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of the informed consent or the non-opposition (when applicable)
* Informed and willing to sign an informed consent form (ICF) approved by IRB or EC (when applicable)
* Willing and able to comply with the requirements of the study protocol
* Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:

  * Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
  * Fracture sequelae
  * Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction
  * Proximal humerus bone defect (reverse configuration)

Exclusion Criteria:

* Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
* Patient belongs to a vulnerable group of subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)
* Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)

Primary outcomes:
measure: ASES Score = American Shoulder and Elbow Surgeons Score
timeFrame: 24 Month
Secondary outcomes:
measure: Constant Score
timeFrame: 24 Month
measure: SANE
timeFrame: 24 Month
measure: EQ-5D-5L
timeFrame: 24 Month
measure: Patient Satisfaction
timeFrame: 24 Month
measure: Radiographic Findings
timeFrame: 24 Month
measure: Tuberosity healing
timeFrame: 12 Month
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: More Foundation
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences
state: Arkansas
city: Rancho Mirage
country: United States
facility: Eisenhower Health Desert Orthopedic Center
state: California
city: San Francisco
country: United States
facility: California Pacific Orthopaedics
state: California
city: Hudson
country: United States
facility: The Center for Bone and Joint Disease
state: Florida
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Columbia
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Houston
country: United States
facility: University of Texas/UT Health
state: Texas
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: