ClinConnect ClinConnect Logo
Search / Trial NCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

Launched by EXACTECH · Nov 1, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

The Exactech Shoulder Post Market Clinical Follow-up Study is a clinical trial aimed at understanding how well shoulder replacement surgery works over time for patients with various shoulder conditions, such as arthritis or rotator cuff tears. The study will track participants for at least 10 years to gather information on the safety and effectiveness of the shoulder implant.

To be eligible for the study, participants must be at least 21 years old and need shoulder replacement surgery or have already had the surgery. They should be expected to live for at least two more years after the procedure, and they must agree to follow the study guidelines. Participants will have regular check-ups to assess their progress. It's important to note that certain health conditions, infections, or specific complications may disqualify someone from joining the study. Overall, this trial will help improve the future of shoulder surgeries by providing valuable long-term data.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
  • Patient is skeletelly mature
  • 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)

About Exactech

Exactech is a leading orthopedic device company committed to improving patient outcomes through innovative solutions in joint reconstruction, trauma, and spine. With a focus on advanced technologies and extensive clinical research, Exactech develops a comprehensive range of implants and instrumentation designed to enhance surgical precision and postoperative recovery. Their dedication to quality, safety, and efficacy is reflected in their robust clinical trial initiatives, which aim to validate the performance of their products and expand the horizons of orthopedic care. By collaborating with healthcare professionals and institutions, Exactech strives to deliver transformative solutions that empower both surgeons and patients alike.

Locations

Jacksonville, Florida, United States

Leicester, , United Kingdom

Ipswich, , United Kingdom

London, Ontario, Canada

Nottingham, , United Kingdom

Greenville, South Carolina, United States

Limoges, , France

Fort Collins, Colorado, United States

Denver, Colorado, United States

Rockford, Illinois, United States

Bedford, , United Kingdom

Redwood City, California, United States

Rennes, , France

New York, New York, United States

Laguna Woods, California, United States

Gainesville, Florida, United States

Palm Beach Gardens, Florida, United States

Palm Beach Gardens, Florida, United States

Tampa, Florida, United States

Augusta, Georgia, United States

Detroit, Michigan, United States

New York, New York, United States

Asheville, North Carolina, United States

Akron, Ohio, United States

Charleston, South Carolina, United States

Franklin, Tennessee, United States

Virginia Beach, Virginia, United States

Pewaukee, Wisconsin, United States

Cavaillon, , France

Mérignac, , France

Catania, , Italy

Eboli, , Italy

Reading, Berks, United Kingdom

Yeovil, Summerset, United Kingdom

Bath, , United Kingdom

Gloucester, , United Kingdom

Manchester, , United Kingdom

Stockton, California, United States

Schaumburg, Illinois, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Jonathan Wright, MD

Principal Investigator

UF Health Orthopaedics and Sports Medicine Institute

Young Kwon, MD

Principal Investigator

Hospital for Joint Diseases - NYU Langone Health

Richard Friedman, MD

Principal Investigator

Charleston Orthopaedic Associates

Richard Jones, MD

Principal Investigator

Southeastern Orthopedics and Spine

Howard Routman, DO

Principal Investigator

Florida Atlantis Orthopaedics

Ryan Simovitch, MD

Principal Investigator

Palm Beach Orthopaedic Institute

Geoffrey Abrams, MD

Principal Investigator

Stanford Health Care

Pierre Henri Flurin, MD

Principal Investigator

Centre de l'Arthrose

Yann Marczuk, MD

Principal Investigator

Clinique Chenieux

Harry Brownlow, MD

Principal Investigator

Circle Health Group

Oliver Donaldson, MD

Principal Investigator

Yeovil District Hospital NHS Foundation

Chris Roberts, MD

Principal Investigator

Ipswich Hospital

Chris Peach, MD

Principal Investigator

University Hospital South Manchester

Angelo Di Giunta, MD

Principal Investigator

Policlinico Morgagni

Alfonso Romano, MD

Principal Investigator

Campolongo Hospital

Sean Grey, MD

Principal Investigator

Orthopaedic and Spine Center of the Rockies

Chad Manke, MD

Principal Investigator

Altantic Orthopaedics Specialists

Rick Papandrea, MD

Principal Investigator

Orthopaedic Associates of Wisconsin

Andrew Chambler, MD

Principal Investigator

The Sulis Hospital Bath

Curt Noel, MD

Principal Investigator

Crystal Clinic Orthopaedic

Stephen Parada, MD

Principal Investigator

Orthopedic and Sports Medicine

Ari Youderian, MD

Principal Investigator

South County Orthopedic Specialists

Ian Byram, MD

Principal Investigator

Bone and Joint Institute of Tennessee

Tewfik Benkalfate, MD

Principal Investigator

Clinique Mutualiste la Sagesse

Peter McCann, MD

Principal Investigator

Lenox Health Greenwich Village

Stephanie Muh, MD

Principal Investigator

Henry Ford Health

Bradley Schoch, MD

Principal Investigator

Mayo Clinic

Stephan Pill, MD

Principal Investigator

Steadman Hawkins Clinic of the Carolinas

Scott Trenhaile, MD

Principal Investigator

OrthoIllinois

Bryan Butler, MD

Principal Investigator

Orthopaedic Medical Group of Tampa Bay

Ben Gooding, MD

Principal Investigator

Nottingham City Hospital

Brad Carofino, MD

Principal Investigator

Altantic Orthopaedics Specialist

Ben Sears, MD

Principal Investigator

Western Orthopaedics

Kenneth Faber, MD

Principal Investigator

St Joseph's Health Care

Jaicharan Iyengar, MD

Principal Investigator

Alpine Orthopaedic Medical Group

Oke Anakwenze, MD

Principal Investigator

Duke Department of Orthopedic Surgery

Thomas Obermeyer, MD

Principal Investigator

Barrington Orthopedic

Alison Armstrong, MD

Principal Investigator

Leicester General Hospital

George Malal, MD

Principal Investigator

Bedford Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials