Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

NCT05615246 | Terminated

• 1 other identifier: CR18-001
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.

Conditions

Osteoarthritis Shoulder; Rheumatoid Arthritis; Oncology

Outcome Measures

Primary Outcomes (7)

• SST-12

  Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%

  Through study completion, an average of 1 per year

• SPADI

  Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities

  Through study completion, an average of 1 per year

• Constant

  Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain

  Through study completion, an average of 1 per year

• ASES

  American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

  Through study completion, an average of 1 per year

• UCLA

  University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes

  Through study completion, an average of 1 per year

• TESS

  Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome

  Through study completion, an average of 1 per year

• MSTS

  Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score

  Through study completion, an average of 1 per year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients who meet eligibility criteria * Patients who consent to participate to return for follow-up visits out to 10 years or longer

You may qualify if:

• Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
• Patient is at least 21 years of age
• Patient is expected to survive at least 2 years beyond surgery
• Patient is willing to participate by complying with pre- and postoperative visit requirements
• Patient is willing and able to read and sign a study informed consent form

You may not qualify if:

• Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
• Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
• Neuromuscular disorders that do not allow control of the joint
• SIgnigicant injury to the brachial plexus
• Non-functional deltoid muscles
• Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
• The patient is unwilling or unable to comply with the post-operative care instructions
• Alcohol, drug, or other subtance abuse
• Any disease state that could adversely affect the function or longevity of the implant
• Patient is pregnant
• Patient is a prisoner
• Patient has a physical or mental condition that would invalidate the results

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Western Orthopaedics Research and Education Foundation

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Neoplasms

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: September 5, 2018
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

US (1)