A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorMayo Clinic

About this trial

The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Shoulder arthritis

Intact rotator cuff

Glenoid retroversion less than 25°

Disqualifiers

Rotator cuff insufficiency

Fracture deformity/sequelae

Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)

Current or previous infection of shoulder

Trial design

Design model

Parallel

Treatments tested in this trial

  • aTSA

    Procedure/Surgery

    Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.

  • rTSA

    Procedure/Surgery

    Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Anatomic total shoulder arthroplasty (aTSA)Other 1 intervention
Group B: Reverse total shoulder arthroplasty (rTSA)Other 1 intervention

Trial outcomes

Primary outcomes

1

American Shoulder and Elbow Surgeons (ASES) Questionnaire score

The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.

Time frame
1 year

Secondary outcomes

1

Change in Visual Analog Scale (VAS) Score

The Visual Analog Scale (VAS) is a 1 item self-report survey that asks the subject to rate the level of pain on a scale of 0 (no pain) - 10 (worst imaginable pain).

Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
2

Change in Single Assessment Numeric Evaluation (SANE) Score

The Single Assessment Numeric Evaluation (SANE) is a 2 item self-report survey that asks subjects to rate the percent of normal range on both the affected joint/region and the opposite joint/region. Scores range from 0% - 100%, with 100% indicating normal range.

Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
3

Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score

The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.

Time frame
Baseline, 6 weeks, 3 months, 6 months, 24 months
4

Change in Shoulder Subjective Value (SSV) Score

The Subjective Shoulder Value (SSV) is 1 item self-report survey that asks subjects to rate their overall shoulder function as a percentage of a "normal" (100%) shoulder.

Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

Other outcomes

Sponsors and contacts

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