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Exactech Shoulder Post Market Clinical Follow-up Study

Sponsor: Exactech

NCT ID: NCT05603728

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 293 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
21 Years and over
Who
All
Number of participants
20,000
Started
2007-07-19
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for osteo arthritis shoulders
  • • Clinical study - 20,000 participants
  • • 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

Who can take part?

  • • Ages 21 Years and over
  • • Diagnosed with osteo arthritis shoulders

Where?

  • • Reading - Circle Health Group
  • • Yeovil - Yeovil District Hospital NHS Foundation Trust
  • • Bath - The Sulis Hospital Bath
  • • Bedford - Bedford Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Osteo Arthritis ShouldersOsteonecrosisRotator Cuff TearsRotator Cuff Tear ArthropathyAnkylosing SpondylitisPost-traumatic OsteoarthritisRheumatoid ArthritisFractureInfections

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 21 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 agreement to take part form

Who cannot take part

  • ✗Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is...
  • ✗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
See the full 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)

Where Is This Study? (8 UK sites)

Circle Health Group

Reading RG2 7AU, United Kingdom

Recruiting
Site contact (verified)
Richard Forbes0118 922 6888

Yeovil District Hospital NHS Foundation Trust

Yeovil BA21 4AT, United Kingdom

Recruiting
Site contact (verified)
Oliver Donaldson01935 475122

The Sulis Hospital Bath

Bath BA2 8SQ, United Kingdom

Recruiting
Site contact (verified)
Darren James01761 422222

Bedford Hospital

Bedford MK42 9DJ, United Kingdom

Recruiting

Ipswich Hospital

Ipswich IP4 5PD, United Kingdom

Recruiting
Site contact (verified)
David B Smith01473 712233

Leicester General Hospital

Leicester LE5 4PW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

University Hospital South Manchester

Manchester M23 9LT, United Kingdom

Recruiting
Site contact (verified)
Rebecca Carter0161 945 8203

Nottingham University Hospital

Nottingham, United Kingdom

Recruiting
Site contact (verified)
Donna King0115 924 9924

How to Get in Touch

Rachael Craig

Sponsor contact

CONTACT

1-833-423-8482 rachael.craig@advita.com

Sandrine Angibaud

Sponsor contact

CONTACT

1-833-423-8482 sandrine.angibaud@advita.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09