Exactech Shoulder Post Market Clinical Follow-up Study

Sponsor

Exactech (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05603728

Collaborator

(none)

20,000

Enrollment

Locations

260.9

Anticipated Duration (Months)

588.2

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Shoulders Osteonecrosis Rotator Cuff Tears Rotator Cuff Tear Arthropathy Ankylosing Spondylitis Post-traumatic Osteoarthritis Rheumatoid Arthritis Fracture Infections

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Sep 30, 2031

Outcome Measures

Primary Outcome Measures

Constant [Through study completion, an average of 1 per year]
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
ASES [Through study completion, an average of 1 per year]
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
Oxford Score (may be used as an optional form for surgeons in the United Kingdom) [Through study completion, an average of 1 per year]
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
TESS (may be used as specific forms related to the pre-operative condition/diagnosis) [Through study completion, an average of 1 per year]
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
MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) [Through study completion, an average of 1 per year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South County Orthopedic Specialists	Laguna Woods	California	United States	92637
2	Stanford Health Care	Redwood City	California	United States	94063
3	Western Orthopaedics	Denver	Colorado	United States	80218
4	Orthopaedic and Spine Center of the Rockies	Fort Collins	Colorado	United States	80525
5	UF Health Orthopaedics and Sports Medicine Institute	Gainesville	Florida	United States	32607
6	Mayo Clinic	Jacksonville	Florida	United States	32224
7	Palm Beach Orthopaedic Institute	Palm Beach Gardens	Florida	United States	33401
8	Florida Atlantis Orthopedics	Palm Beach Gardens	Florida	United States	33410
9	Orthopaedic Medical Group of Tampa Bay	Tampa	Florida	United States	33619
10	Orthopedic and Sports Medicine	Augusta	Georgia	United States	30909
11	OrthoIllinois	Rockford	Illinois	United States	61107
12	Henry Ford Health	Detroit	Michigan	United States	48067
13	Hospital for Joint Diseases - NYU Langone Health	New York	New York	United States	10003
14	Lenox Health Greenwich Village	New York	New York	United States	10011
15	Southeastern Sports Medicine and Orthopedics	Asheville	North Carolina	United States	28803
16	Crystal Clinic Orthopaedic	Akron	Ohio	United States	44333
17	Charleston Orthopaedic Associates	Charleston	South Carolina	United States	29414
18	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina	United States	29615
19	Bone and Joint Institute of Tenessee	Franklin	Tennessee	United States	37067
20	Atlantic Orthopaedics Specialists	Virginia Beach	Virginia	United States	23320
21	Orthopaedic Associates of Wisconsin	Pewaukee	Wisconsin	United States	53072
22	Cite Sante	Cavaillon		France	84300
23	Clinique Chenieux	Limoges		France	87039
24	Centre de l'arthrose	Mérignac		France	33700
25	Clinique Mutualiste La Sagesse	Rennes		France	35043
26	Policlinico Morgagni	Catania		Italy	95125
27	Campolongo Hospital	Eboli		Italy	84025
28	Circle Health Group	Reading	Berks	United Kingdom	RG2 7AU
29	Yeovil District Hospital NHS Foundation Trust	Yeovil	Summerset	United Kingdom	BA21 4AT
30	The Sulis Hospital Bath	Bath		United Kingdom	BA2 8SQ
31	Gloucester Royal Hospital Foundation Trust	Gloucester		United Kingdom	GL1 3NN
32	Ipswich Hospital	Ipswich		United Kingdom	IP4 5PD
33	University Hospital South Manchester	Manchester		United Kingdom	M23 9LT
34	Nottingham University Hospital	Nottingham		United Kingdom

Sponsors and Collaborators

Exactech

Investigators

Principal Investigator: Jonathan Wright, MD, UF Health Orthopaedics and Sports Medicine Institute
Principal Investigator: Young Kwon, MD, Hospital for Joint Diseases - NYU Langone Health
Principal Investigator: Richard Friedman, MD, Charleston Orthopaedic Associates
Principal Investigator: Richard Jones, MD, Southeastern Sports Medicine and Orthopedics
Principal Investigator: Howard Routman, DO, Florida Atlantis Orthopaedics
Principal Investigator: Ryan Simovitch, MD, Palm Beach Orthopaedic Institute
Principal Investigator: Geoffrey Abrams, MD, Stanford Health Care
Principal Investigator: Pierre Henri Flurin, MD, Centre de l'Arthrose
Principal Investigator: Yann Marczuk, MD, Clinique Chenieux
Principal Investigator: Stephane Menager, MD, Cite Sante
Principal Investigator: Ahmed Juanroyee, MD, Gloucester Royal Hospital Foundation Trust
Principal Investigator: Harry Brownlow, MD, Circle Health Group
Principal Investigator: Oliver Donaldson, MD, Yeovil District Hospital NHS Foundation
Principal Investigator: Chris Roberts, MD, Ipswitch Hospital
Principal Investigator: Chris Peach, MD, University Hospital South Manchester
Principal Investigator: Angelo Di Giunta, MD, Policlinico Morgagni
Principal Investigator: Alfonso Romano, MD, Campolongo Hospital
Principal Investigator: Sean Grey, MD, Orthopaedic and Spine Center of the Rockies
Principal Investigator: Chad Manke, MD, Altantic Orthopaedics Specialists
Principal Investigator: Rick Papandrea, MD, Orthopaedic Associates of Wisconsin
Principal Investigator: Andrew Chambler, MD, The Sulis Hospital Bath
Principal Investigator: Curt Noel, MD, Crystal Clinic Orthopaedic
Principal Investigator: Stephen Parada, MD, Orthopedic and Sports Medicine
Principal Investigator: Ari Youderian, MD, South County Orthopedic Specialists
Principal Investigator: Ian Byram, MD, Bone and Joint Institute of Tennessee
Principal Investigator: Tewfik Benkalfate, MD, Clinique Mutualiste la Sagesse
Principal Investigator: Peter McCann, MD, Lenox Health Greenwich Village
Principal Investigator: Stephanie Muh, MD, Henry Ford Health
Principal Investigator: Bradley Schoch, MD, Mayo Clinic
Principal Investigator: Stephan Pill, MD, Steadman Hawkins Clinic of the Carolinas
Principal Investigator: Scott Trenhaile, MD, OrthoIllinois
Principal Investigator: Bryan Butler, MD, Orthopaedic Medical Group of Tampa Bay
Principal Investigator: Ben Gooding, MD, Circle Nottingham Limited
Principal Investigator: Brad Carofino, MD, Altantic Orthopaedics Specialist
Principal Investigator: Ben Sears, MD, Western Orthopaedics