Clinical trial NCT04827277: TSA Versus RSA in Patients >75
Official title: A Prospective Randomized Clinical Trial Comparing Total Shoulder Arthroplasty vs Reverse Shoulder Arthroplasty in Patients >75 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Shoulder Arthoplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 108
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative satisfaction
timeFrame: 2 years
measure: Postoperative Satisfaction
timeFrame: 2 years
measure: Postoperative Pain
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: