RecruitingNot ApplicableNCT04629391

Anatomic TSA Vs RTSA for Glenohumeral Arthritis

Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. a Randomized Prospective Study


Sponsor

La Tour Hospital

Enrollment

296 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.


Eligibility

Min Age: 65 YearsMax Age: 85 Years

Inclusion Criteria2

  • Primary glenohumeral arthritis,
  • Intact rotator cuff,

Exclusion Criteria18

  • Patients between 65 and 85 years old
  • Informed Consent as documented by signature (Appendix Informed Consent Form).
  • B2 glenoid with \> 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
  • B3 and C type glenoids,
  • Full thickness rotator cuff tear,
  • Acute or malunited proximal humeral fracture,
  • Chronic locked dislocation
  • Rheumatoid arthritis,
  • Revision surgery or surgical antecedents,
  • Tumors,
  • Axillary nerve damage,
  • Non-functioning deltoid muscle,
  • Glenoid vault deficiency precluding baseplate fixation,
  • Infection and neuropathic joints,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Patients incapable of judgement or under tutelage,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.

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Interventions

DEVICETotal shoulder arthroplasty

A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.


Locations(1)

La Tour Hospital

Meyrin, Switzerland

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NCT04629391


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