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

ConditionShoulder Arthritis
Trial statusNot yet recruiting
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

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

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: