Exactech Shoulder Post Market Clinical Follow-up Study

Rheumatoid Arthritis Clinical Trial

Official title:

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603728
• Other study ID #: CR09-005
• Status: Recruiting
• Start date: January 2010
• 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 and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• 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, implantation should be delayed until infection is resolved

• Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis

• Medial humeral bone loss resulting in compromised humeral stem fixation

• Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation

• Neuromuscular disorders that do not allow control of the joint

• Significant 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 adversaly affect the function or longevity of the implant

• Patient is pregnant

• Patient is a prisoner

• Patient is contraindicated for the surgery

• Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)

• Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)

• Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)

• Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Fracture
• Infections
• Osteo Arthritis Shoulders
• Osteoarthritis
• Osteonecrosis
• Post-traumatic Osteoarthritis
• Rheumatoid Arthritis
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy
• Rotator Cuff Tears
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
France	Cite Sante	Cavaillon
France	Clinique Chenieux	Limoges
France	Centre de l'arthrose	Mérignac
France	Clinique Mutualiste La Sagesse	Rennes
Italy	Policlinico Morgagni	Catania
Italy	Campolongo Hospital	Eboli
United Kingdom	The Sulis Hospital Bath	Bath
United Kingdom	Gloucester Royal Hospital Foundation Trust	Gloucester
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	University Hospital South Manchester	Manchester
United Kingdom	Nottingham University Hospital	Nottingham
United Kingdom	Circle Health Group	Reading	Berks
United Kingdom	Yeovil District Hospital NHS Foundation Trust	Yeovil	Summerset
United States	Crystal Clinic Orthopaedic	Akron	Ohio
United States	Southeastern Sports Medicine and Orthopedics	Asheville	North Carolina
United States	Orthopedic and Sports Medicine	Augusta	Georgia
United States	Charleston Orthopaedic Associates	Charleston	South Carolina
United States	Western Orthopaedics	Denver	Colorado
United States	Henry Ford Health	Detroit	Michigan
United States	Orthopaedic and Spine Center of the Rockies	Fort Collins	Colorado
United States	Bone and Joint Institute of Tenessee	Franklin	Tennessee
United States	UF Health Orthopaedics and Sports Medicine Institute	Gainesville	Florida
United States	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina
United States	Mayo Clinic	Jacksonville	Florida
United States	South County Orthopedic Specialists	Laguna Woods	California
United States	Hospital for Joint Diseases - NYU Langone Health	New York	New York
United States	Lenox Health Greenwich Village	New York	New York
United States	Florida Atlantis Orthopedics	Palm Beach Gardens	Florida
United States	Palm Beach Orthopaedic Institute	Palm Beach Gardens	Florida
United States	Orthopaedic Associates of Wisconsin	Pewaukee	Wisconsin
United States	Stanford Health Care	Redwood City	California
United States	OrthoIllinois	Rockford	Illinois
United States	Orthopaedic Medical Group of Tampa Bay	Tampa	Florida
United States	Atlantic Orthopaedics Specialists	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Countries where clinical trial is conducted

United States,  France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Oxford Score (may be used as an optional form for surgeons in the United Kingdom)	Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability	Through study completion, an average of 1 per year
Primary	TESS (may be used as specific forms related to the pre-operative condition/diagnosis)	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 (may be used as specific forms related to the pre-operative condition/diagnosis)	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