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Anatomic TSA vs RTSA for Glenohumeral Arthritis

ConditionArthritis Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorLa Tour Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Primary glenohumeral arthritis,

Intact rotator cuff,

No important glenoid bone loss (cf

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total shoulder arthroplasty

    Device

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

Treatment groups

296 Participants
are divided into 2 treatment groups
Group A: Anatomic TSAActive comparator 1 intervention
Group B: RTSAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in American Shoulder and Elbow Surgeons score (ASES)

General clinical score (0-100, with 100 being the best score possible)

Time frame
Between baseline and 2 postoperative years

Secondary outcomes

1

Change in Subjective Shoulder Value (SSV)

General clinical score (0-100, with 100 being the best score possible)

Time frame
Between baseline and 2 postoperative years
2

Change in Range of motion in degrees

(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)

Time frame
Between baseline and 2 postoperative years
3

Complication rates

Time frame
2 postoperative years.
4

Change in pain on visual analogic scale (pVAS)

General clinical score (0-10, with 10 the worst score possible)

Time frame
Between baseline and 2 postoperative years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

La Tour Hospital

Lead sponsor

Source ClinicalTrials.gov
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