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Exactech Shoulder Post Market Clinical Follow-up Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how safe shoulder replacements are and how well they work over time, using health checks and X-rays. It is for people who need or have already had a shoulder replacement. People will be followed for at least 10 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You need a shoulder replacement or have already had one.
  • Your bones have finished growing.
  • You are expected to live at least 2 years after surgery.
  • You are willing to attend required visits before and after surgery.
  • You are willing and able to read and sign a form agreeing to join the study.

Who can't join

  • You have a bone infection in your upper arm or shoulder blade. Surgery must wait if an infection elsewhere in your body is suspected or confirmed, until it clears.
  • Your bone is too weak, poorly shaped, or missing in areas needed to hold the replacement firmly in place.
  • You have a nerve or muscle disorder that prevents joint control, a major injury to the shoulder nerve network, or a shoulder muscle called the deltoid that does not work.
  • Your surgeon expects early replacement failure because of your age, weight, or activity level; you have a disease that could harm the replacement's function or lifespan; or surgery is not safe for you.
  • You cannot or will not follow care instructions after surgery, or you misuse alcohol, drugs, or other substances.
  • You are pregnant or a prisoner.
  • For the stemless shoulder replacement: you are having repeat surgery after a replacement with a stem in the upper arm bone, or you have an allergy or sensitivity to the replacement's metals or other materials.
  • For the stemless shoulder replacement: you have certain new breaks near the top of the upper arm bone. These include breaks with shifted bone bumps; shifted breaks in 3 or 4 parts for partial replacement; breaks with shoulder joint failure for total replacement; or breaks with joint wear and an unrepairable shoulder tendon tear that lets the arm bone move upward for reverse replacement.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (24)

CA

CO

FL

GA

IL

MI

NC

NY

OH

SC

TN

VA

WI