Current Clinical Trials

Perform® Humeral System - Fracture Study (PFX)
  1. David Savin, MD
    David Savin, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started June 2023
  5. David Savin, MD
  6. Accepting new patients

Description

Summary

Clinical Investigation Plan Tornier Perform® Humeral System - Fracture Study (PFX). Tornier Perform® Humeral System - Fracture Study (PFX) is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. The objective of this study is to collect preoperative, intra operative, short, intermediate, mid-term and long-term data on the related clinical complications and functional outcomes of the device to demonstrate the safety and performance of these implants in a real-world setting

Official Title

Tornier Perform® Humeral System - Fracture Study (PFX)

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 h... more
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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.

Keywords

Traumatic Arthropathy of Shoulder

Eligibility

for people 18 Years and up
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 ... more
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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)

Lead Scientists at Eisenhower Health

David Savin, MD
David D.Savin, MD, is a fellowship-trained orthopedic surgeon. He specializes in the diagnosis and treatment of shoulder and elbow disorders, as well as general orthopedics and fracture care. He has significant experience performing arthroscopic management of all shoulder injuries, as well as management of shoulder arthritis with both anatomic and reverse shoulder replacements. His surgical skill set also includes management of shoulder and elbow trauma and common elbow injuries.“I am... more
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David D.Savin, MD, is a fellowship-trained orthopedic surgeon. He specializes in the diagnosis and treatment of shoulder and elbow disorders, as well as general orthopedics and fracture care. He has significant experience performing arthroscopic management of all shoulder injuries, as well as management of shoulder arthritis with both anatomic and reverse shoulder replacements. His surgical skill set also includes management of shoulder and elbow trauma and common elbow injuries.

“I am grateful to have the ability to help my patients alleviate pain, restore function and return to an active lifestyle.”

Dr. Savin is passionate about helping his patients restore function and stay active after shoulder and elbow injuries. He works with athletes of all ages including high school, college and weekend warriors and his experience includes working with professional teams, such as the Chicago Bulls and Chicago White Sox.

Dr. Savin earned his Bachelor of Science in physiological sciences with Latin honors at the University of California, Los Angeles (UCLA). He continued his medical education at UCLA at the David Geffen School of Medicine. He then moved to Chicago where he completed his surgical internship and orthopedic surgical residency at the University of Illinois. Thereafter, he completed a fellowship in shoulder and elbow surgery at the renowned Midwest Orthopaedics at Rush University Medical Center.

Dr. Savin has conducted extensive research on shoulder and elbow management and surgery on which he has given over 30 national and international presentations and authored dozens of peer-reviewed publications and several book chapters. He is also an active member of the American Academy of Orthopaedic Surgeons.

Dr. Savin, a California native, lives with his wife in Palm Desert. In his free time, he enjoys traveling, hiking, cycling, golf and photography.

Co-Investigators

  1. Karimdad Otarodi, MD

Clinical Study Details

  1. Accepting new patients
  2. study started June 2023
  3. Observational
  4. Expecting 120 study participants
  5. May 08, 2024