Anatomic TSA vs RTSA for Glenohumeral Arthritis

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    296
  • sponsor
    La Tour Hospital
Updated on 5 May 2022

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.

Description

Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.

Reverse total shoulder arthroplasty (RTSA) was designed with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.

Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.

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.The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.

Details
Condition Arthritis Shoulder
Treatment Total Shoulder Arthroplasty
Clinical Study IdentifierNCT04629391
SponsorLa Tour Hospital
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary glenohumeral arthritis
Intact rotator cuff
No important glenoid bone loss (cf exclusion criteria)
Patients between 65 and 85 years old
Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note