Musculoskeletal Diseases

All Conditions

Skin and Connective Tissue Diseases

Immune System Diseases

Osteoarthritis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Rachael Craig

Sandrine Angibaud

Libby Mauter

Armodios M Hatzidakis, MD

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.

Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty

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%

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

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

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

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

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

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

Study title	NCT ID	Conditions	Eligibility	Organization
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)	NCT05615246	Osteoarthritis ... Rheumatoid Arth... Oncology	21 Years -	Exactech
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)	NCT05615246	Osteoarthritis ... Rheumatoid Arth... Oncology	21 Years -	Exactech
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)	NCT05615246	Osteoarthritis ... Rheumatoid Arth... Oncology	21 Years -	Exactech

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