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Recruiting NCT03804853

Rehabilitation Following Reverse Total Shoulder Arthroplasty

No phase Interventional Shoulder Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rehabilitiation.
Who it may be relevant to
Registry conditions: Shoulder Osteoarthritis. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immediate Accelerated Shoulder Rehabilitation Versus a Standard Protocol Following Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial

Overview

Reverse total shoulder arthroplasty (RTSA) has been successful in patients with rotator cuff arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA report pain relief and functional range of motion. It has been more than 20 years since the advent of the RTSA construct but an immediate post-operative rehabilitation with active shoulder range of motion has not been prospectively studied in comparison to the traditional post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to prospectively follow our patients following RTSA undergoing an immediate active shoulder rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion. Investigators plan to document clinical outcomes, complications and cost effectiveness out to 1 year. The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the health of the population, improve the experience of each individual, and make healthcare affordable by decreasing the total cost of care.

Interventions

  • Other Rehabilitiation
    This study will be a non-blinded randomized controlled outcomes study evaluating outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively from a primary reverse total shoulder arthroplasty with two different post-operative physical rehabilitation protocols. There will be 2 groups, one undergoing the immediate active shoulder physical therapy protocol consisting of four quadrant stretches and full active motion of the shoulder from post op day 1 in the hospital. The

Primary outcome measures

  • American Society for Elbow and Shoulder Score [Time frame: Pre-operatively]
  • American Society for Elbow and Shoulder Score [Time frame: 2 weeks]
  • American Society for Elbow and Shoulder Score [Time frame: 3 months]
  • American Society for Elbow and Shoulder Score [Time frame: 6 months]
  • American Society for Elbow and Shoulder Score [Time frame: 1 year]
  • Simple Shoulder Test [Time frame: Pre-operatively]
  • Simple Shoulder Test [Time frame: 2 weeks]
  • Simple Shoulder Test [Time frame: 3 months]
  • Simple Shoulder Test [Time frame: 6 months]
  • Simple Shoulder Test [Time frame: 1 year]
Secondary outcome measures (1)
  • Subscapularis Tear [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • > 55 years of age.
  • Candidate for a primary reverse total shoulder arthroplasty.
  • Capable of completing self-administered questionnaires.
  • Be willing and able to return for all study-related follow-up procedures.
  • Able and willing to give informed consent.
  • Proficient in the English language.

Exclusion criteria

In-Clinic:

  • Patients planning on undergoing a Primary Reverse Shoulder Total Arthroplasty due to proximal humeral fracture.
  • Previous shoulder surgery including previous total shoulder arthroplasty or reverse total shoulder arthroplasty or hemiarthroplasty, or instability repairs
  • Active bacterial infection of the shoulder.
  • Any concomitant shoulder procedure.
  • Additional ipsilateral or contralateral upper limb pathology that requires active treatment (i.e. surgery or brace).
  • Inflammatory arthropathy.
  • Diagnosed with Rheumatoid arthritis
  • Diagnosed with gout.
  • Subject is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery.
  • Peripheral vascular disease or other vascular disorders that would impair healing.
  • Peripheral neuropathy or other neurological disorders that may impair the patient to ambulate.
  • Patient is on workers compensation.
  • Any condition requiring chemotherapy.
  • Active tobacco user or former tobacco user who is not free of using tobacco for 8 weeks.
  • Uncontrolled Diabetes Mellitus with an HbA1C > 7.5%.
  • Current drug or alcohol abuse.
  • Major medical illness (life expectancy less then 2 years or unacceptably high operative risk)
  • Suspicion of cervical radiculopathy or myelopathy.
  • Deltoid insufficiency on physical examination.

Intra-operative:

  • Iatrogenic glenoid fracture

Post-operative:

  • Neurological injury of the upper extremity.
  • Complications from Primary Reverse Shoulder Total Arthroplasty (i.e. post-operative infection, bleeding, hardware failure).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • TRIA Orthopaedic Center — Bloomington

Identifiers

NCT: NCT03804853 · 18-259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗