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NCT Number: NCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

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.

Recruiting

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Key information

Conditions

Osteo Arthritis Shoulders Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Chondrocalcinosis Connective Tissue Diseases Crystal Arthropathies Fracture Fractures, Bone Immune System Diseases Infections Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Osteoarthritis Rheumatic Diseases Rheumatoid Arthritis Rotator Cuff Injuries Rotator Cuff Tear Arthropathy Rotator Cuff Tears Rupture Shoulder Injuries Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Tendon Injuries Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Joseph's Health Care, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Constant

    Time frame: 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

  2. ASES

    Time frame: 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

  3. Oxford Score (may be used as an optional form for surgeons in the United Kingdom)

    Time frame: 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

  4. TESS (may be used as specific forms related to the pre-operative condition/diagnosis)

    Time frame: 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

  5. MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachael Craig

CONTACT

[email protected]

352-377-1140

Sandrine Angibaud

CONTACT

[email protected]

352-377-1140

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2030
Study completion
2031
First posted
Nov 3, 2022
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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