Perform® Humeral System - Fracture Study (PFX) (PFX)

Tornier Perform® Humeral System - Fracture Study

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Arthritis; Revision of Other Devices if Sufficient Bone Stock Remains; Fracture Humerus; Traumatic Arthropathy of Shoulder
• Intervention / Treatment: Device: Tornier Perform® Humeral System - Fracture

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 and intra operative data can be collected retrospectively up to 2 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Monica Fleeman; Phone Number: 251-465-5969; Email: monica.fleeman@stryker.com
• Study Contact Backup: Name: Jennifer Seidman; Phone Number: 901-633-8616; Email: jennifer.seidman@stryker.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Recruiting
      • MoRe Foundation
      • Contact: Leesa Maczko; Phone Number: 623-241-8639; Email: Leesa.Maczko@more-foundation.org
      • Principal Investigator: Niloofar Dehghan, MD
      • Sub-Investigator: Michael Amini, MD
      • Sub-Investigator: Theresa Pak, MD
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas Medical Sciences
      • Contact: Dana Garrison; Phone Number: 501-231-1193; Email: dlgarrison@uams.edu
      • Principal Investigator: Justin Rabinowitz, MD
  • California
    • Rancho Mirage, California, United States, 92270
      • Recruiting
      • Eisenhower Health Desert Orthopedic Center
      • Contact: Lainie Hughes; Phone Number: 8237 760-837-8237; Email: LHughes@eisenhowerhealth.org
      • Principal Investigator: David D Savin, MD
      • Sub-Investigator: Karimdad Amir Otarodi, MD
    • San Francisco, California, United States, 94118
      • Recruiting
      • California Pacific Orthopaedics
      • Principal Investigator: James D Kelly, MD
      • Sub-Investigator: Mark Schrumf, MD
      • Contact: Katie Sisson; Email: ksisson@calpacortho.com
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Contact: Julianne Sefko; Phone Number: 314-747-2496; Email: jsefko@wustl.edu
      • Principal Investigator: Benjamin Zmistowski, MD
      • Sub-Investigator: Alexander Aleem, MD
  • Tennessee
    • Columbia, Tennessee, United States, 38401
      • Recruiting
      • Tennessee Orthopaedic Alliance
      • Contact: Asha Phillips; Phone Number: 1231 615-329-6600; Email: phillipsad@toa.com
      • Principal Investigator: Christopher M Loftis, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas/UT Health
      • Contact: Layla Haidar; Phone Number: 713-962-9954; Email: Layla.Haidar@uth.tmc.edu
      • Principal Investigator: James Gregory, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tornier Perform® Humeral System - Fracture; Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty.	Device: Tornier Perform® Humeral System - Fracture; A replacement of shoulder joints for anatomic and reverse shoulder arthroplasty. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES Score = American Shoulder and Elbow Surgeons Score	11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function	24 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Score	A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. Collected at: 1, 2, 5, and 10 years.	24 Month
SANE	Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. Collected annually through 10 year visit.	24 Month
EQ-5D-5L	Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. Collected annually through 10 year visit..	24 Month
Patient Satisfaction	Single subjective question "How satisfied are you with your shoulder?" Collected annually through 10 year visit.	24 Month
Radiographic Findings	X-rays will be analyzed, when sufficient information is available, for bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification. X-rays will be collected at Baseline, 6 months, 1 year, 2 year, 5 year and 10 year.	24 Month
Tuberosity healing	Tuberosity healing (bone union) (Boileau et al., 2002, 2013, 2019) is expected to be completed post-operatively at 6 months and assessed at 6 months and up to 1 year if tuberosity healing is not achieved at 6 months.	12 Month

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma and Extremities

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2033

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: UE-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes