Clinical trial NCT03547726: Physical Therapy After Reverse Total Shoulder Arthroplasty
Official title: Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups of patients randomized either to receive formal physical therapy in clinic or a self-led at home rehabilitation regimen.
Primary purpose: TREATMENT

Brief summary: A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

Detailed description: A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.

Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.

Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.

The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.

These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.

Eligibility criteria: Inclusion Criteria:

* • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons

Exclusion Criteria:

* • Revision shoulder replacement surgery

  * Mentally incompetent to provide informed consent
  * Non-english speaking
  * Minors (\<18)
  * Pregnant women
  * Prison population
  * Acute Shoulder Fractures

Primary outcomes:
measure: Forward Flexion Range of Motion 1
timeFrame: 3 months followup
Secondary outcomes:
measure: Strength 1
timeFrame: 3 months followup
measure: Simple Shoulder Test Patient Reported Outcome 1
timeFrame: 3 months followup
measure: Strength 2
timeFrame: 6 month followup
measure: Strength 3
timeFrame: 12 months followup
measure: Internal Rotation Range of Motion 1
timeFrame: 3 months followup
measure: External Rotation Range of Motion 1
timeFrame: 3 months followup
measure: Internal Rotation Range of Motion 2
timeFrame: 6 month followup
measure: External Rotation Range of Motion 2
timeFrame: 6 month followup
measure: Forward Flexion Range of Motion 2
timeFrame: 6 months followup
measure: Forward Flexion Range of Motion 3
timeFrame: 12 months followup
measure: Internal Rotation Range of Motion 2
timeFrame: 12 months followup
measure: External Rotation Range of Motion 2
timeFrame: 12 months followup
measure: American Shoulder and Elbow Surgeons Shoulder Score 1
timeFrame: 3 month followup
measure: Simple Shoulder Test Patient Reported Outcome 2
timeFrame: 6 month followup
measure: Simple Shoulder Test Patient Reported Outcome 3
timeFrame: 12 month followup
measure: Single Assessment Numeric Evaluation (SANE) Score 1
timeFrame: 3 month followup
measure: American Shoulder and Elbow Surgeons Shoulder Score 2
timeFrame: 6 month followup
measure: American Shoulder and Elbow Surgeons Shoulder Score 3
timeFrame: 12 month followup
measure: Single Assessment Numeric Evaluation (SANE) Score 2
timeFrame: 6 month followup
measure: Single Assessment Numeric Evaluation (SANE) Score 3
timeFrame: 12 month followup
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amit M Momaya, MD
role: PRINCIPAL_INVESTIGATOR
References: