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Rehabilitation for Shoulder Osteoarthritis (RTSA Trial)
N/A
Recruiting
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
55 years of age
Candidate for a primary reverse total shoulder arthroplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
RTSA Trial Summary
This trial will compare the effects of two different post-operative rehabilitation programs for people who have had a reverse shoulder arthroplasty.
Who is the study for?
This trial is for individuals aged 55 or older who need a primary reverse total shoulder arthroplasty, can fill out questionnaires themselves, and speak English. They must be able to attend follow-up visits and give informed consent. Exclusions include prior shoulder surgeries, infections, bleeding disorders, uncontrolled diabetes (HbA1C > 7.5%), major illnesses with life expectancy under 2 years, tobacco use within the last 8 weeks, drug/alcohol abuse.Check my eligibility
What is being tested?
The study tests immediate active shoulder rehabilitation versus traditional post-operative rehab after reverse total shoulder arthroplasty. It aims to compare clinical outcomes like pain relief and range of motion improvements as well as complications and cost-effectiveness over one year.See study design
What are the potential side effects?
While specific side effects are not listed for the rehabilitative interventions being tested in this trial, general risks may include discomfort during exercises, potential strain on healing tissues leading to inflammation or injury if not performed correctly.
RTSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
I am a candidate for shoulder replacement surgery.
RTSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
American Society for Elbow and Shoulder Score
PROMIS Global 10
Range of Motion
+1 moreSecondary outcome measures
Subscapularis Tear
Other outcome measures
Number of PT Visits
RTSA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate Active Shoulder RehabilitationExperimental Treatment1 Intervention
Group II: Traditional Should RehabilitationActive Control1 Intervention
Find a Location
Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
185 Previous Clinical Trials
3,716,057 Total Patients Enrolled
TRIA Orthopaedic CenterOTHER
3 Previous Clinical Trials
946 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a shoulder socket fracture caused during surgery.I can fill out questionnaires by myself.I am undergoing or have undergone a shoulder procedure.I have had complications from shoulder replacement surgery.I am scheduled for shoulder replacement surgery due to a shoulder fracture.I am 55 years old or older.I have a type of joint inflammation.I might have nerve or spinal cord issues in my neck.I have been diagnosed with gout.I have nerve issues that make it hard for me to walk.I do not have a major illness that would give me less than 2 years to live.My diabetes is not under control, with an HbA1C over 7.5%.I have a blood vessel condition that could affect healing.I have a nerve injury in my arm after surgery.I have been diagnosed with Rheumatoid arthritis.I have had shoulder surgery, including joint replacement or repairs for instability.I have a current shoulder infection.I am a candidate for shoulder replacement surgery.I am on long-term blood thinners or have taken them within the last 10 days.I have an arm condition that needs treatment like surgery or a brace.My shoulder muscle is weak.I need chemotherapy for my condition.You are currently using drugs or alcohol in a harmful or excessive way.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Should Rehabilitation
- Group 2: Immediate Active Shoulder Rehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment phase of this trial still open?
"Per the information shared on clinicaltrials.gov, this research is recruiting currently. It was publicly posted in December 2018 and last updated at the end of February 2022."
Answered by AI
How many participants are involved with this medical investigation?
"Affirmative, the information from clinicaltrials.gov confirms that this medical trial is actively recruiting contributors. The study was first posted on December 12th 2018 and recently updated on February 28th 2022. 74 patients are needed to be recruited at a single site."
Answered by AI
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