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TSA Versus RSA in Patients >75

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Unknown

Conditions

Total Shoulder Arthoplasty

Treatments

Procedure: Reverse Total Shoulder Replacement
Procedure: Anatomic Total Shoulder Replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT04827277
JABB20D.949

Details and patient eligibility

About

Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA.

Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients >75 years of age

Enrollment

108 patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All patients (75 years of age) at the time of surgery
  • Patient is willing to participate by complying with pre and postoperative visit requirements
  • Patient is willing to consent for enrollment
  • Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff

Exclusion criteria

  • Patients under the age of 75
  • Need for any structural graft for repair of the shoulder during surgery
  • Current infection of the proximal humerus or scapula
  • Proximal humerus fracture
  • Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
  • Neuromuscular disorder that does not allow control of the shoulder joint
  • Significant injury to the brachial plexus
  • Diagnosis of inflammatory arthropathy
  • Preoperative diagnosis of full thickness rotator cuff tear
  • >Goutallier Stage 1 rotator cuff atrophy
  • Prior shoulder arthroplasty
  • Non-functioning deltoid muscle
  • Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
  • Patient is a prisoner
  • Patients who are currently involved in any personal injury litigation, or worker's compensation claims.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Reverse total shoulder replacement
Active Comparator group
Description:
Participants will receive a reverse total shoulder arthroplasty
Treatment:
Procedure: Reverse Total Shoulder Replacement
Anatomic total shoulder replacement
Active Comparator group
Description:
Participants will receive an anatomic total shoulder arthroplasty
Treatment:
Procedure: Anatomic Total Shoulder Replacement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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