Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Rheumatoid Arthritis Clinical Trial

— HRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615246
• Other study ID #: CR18-001
• Status: Recruiting
• Start date: September 5, 2018
• Est. completion date: September 30, 2031

Study information

• Verified date: February 2024
• Source: Exactech
• Contact: Rachael Craig
• Phone: 352-377-1140
• Email: rachael.craig[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Oncology
• Osteoarthritis
• Osteoarthritis Shoulder
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Western Orthopaedics Research and Education Foundation	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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