Rehabilitation Following Reverse Total Shoulder Arthroplasty

Study Purpose

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.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 55 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03804853
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

HealthPartners Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Shoulder Osteoarthritis
Arms & Interventions

Arms

Experimental: Immediate Active Shoulder Rehabilitation

Active Comparator: Traditional Should Rehabilitation

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 second group will follow the traditional TRIA physical therapy protocol consisting of PT (standard of care) followed by a gradual return to active range of motion of the shoulder beginning by week 6, calling for 18 physical therapy visits. The physical therapy will occur where the patient is most comfortable receiving it.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TRIA Orthopaedic Center, Bloomington, Minnesota

Status

Recruiting

Address

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431

Site Contact

Megan Reams

[email protected]

952-806-5329