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Reverse vs Anatomic Shoulder Replacement for Shoulder Osteoarthritis (CERVASA Trial)
N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty
- Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3-, 6- and 12-months
Awards & highlights
CERVASA Trial Summary
This trial will compare two surgical procedures for people with advanced shoulder osteoarthritis who are 65 or older. The goal is to determine which procedure produces better results with fewer complications.
Who is the study for?
This trial is for people aged 65 and older with advanced shoulder osteoarthritis who haven't improved after 6 months of non-surgical treatments like painkillers, anti-inflammatory drugs, and physiotherapy. It's not suitable for those with significant muscle paralysis, major illnesses limiting life expectancy or surgical risk, active compensation claims, previous shoulder surgery on the affected side, infections, certain joint conditions or psychiatric issues affecting consent.Check my eligibility
What is being tested?
The study compares two types of shoulder replacement surgeries in patients over 65 with severe osteoarthritis: Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA). Participants will be randomly assigned to one of these procedures to see which offers better function and quality of life outcomes within a year post-surgery.See study design
What are the potential side effects?
Potential side effects from both TSA and RTSA may include infection risks at the surgery site, pain during recovery period, limited range of motion or strength in the operated arm compared to pre-operative levels. There might also be complications such as implant loosening or wear over time.
CERVASA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My shoulder arthritis hasn't improved with standard treatments, and I need surgery.
Select...
My shoulder joint shows advanced cartilage loss.
Select...
I am 65 years old or older.
CERVASA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 3-, 6- and 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3-, 6- and 12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)
Secondary outcome measures
Change in Constant Score
Change in EuroQol EQ-5D-5L quality of life questionnaire
Change in Shoulder Pain
+7 moreCERVASA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reverse Total Shoulder Arthroplasty (RTSA)Experimental Treatment1 Intervention
Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within < 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.
Group II: Total Shoulder Arthroplasty (TSA)Active Control1 Intervention
Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reverse Total Shoulder Arthroplasty (RTSA)
2019
N/A
~110
Find a Location
Who is running the clinical trial?
University Hospital FoundationOTHER
7 Previous Clinical Trials
1,346 Total Patients Enrolled
Canadian Orthopaedic FoundationOTHER
13 Previous Clinical Trials
1,556 Total Patients Enrolled
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,098 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing physiotherapy with exercises and treatments like ultrasound.You have a mental health condition that affects your ability to understand and make informed decisions.My shoulder socket has a deficiency and is tilted backward more than 15 degrees.I have had shoulder surgery on the same side as my current condition.I still have pain and disability after 6 months of standard treatment without surgery.I am currently taking painkillers or anti-inflammatory drugs.I am not willing to participate in follow-up visits for the study.I have Charcot's joint disease.I do not have a major illness that would give me less than a year to live.My shoulder arthritis hasn't improved with standard treatments, and I need surgery.I currently have an infection in my joints or throughout my body.I have significant muscle weakness or paralysis.My shoulder joint shows advanced cartilage loss.I am 65 years old or older.I am under medical management.I have shoulder joint damage due to rotator cuff issues.I need surgery to correct my shoulder joint alignment.My joint cannot be corrected to almost straight with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Reverse Total Shoulder Arthroplasty (RTSA)
- Group 2: Total Shoulder Arthroplasty (TSA)
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.
Are any new participants being accepted into the trial currently?
"Affirmative, clinicaltrials.gov confirms that this medical experiment is actively enrolling participants. The trial was first published on May 30th 2022 and has been updated as recently as July 14th 2022. 40 volunteers are needed across 8 various sites for the study to be successful."
Answered by AI
What is the maximum participant capacity for this trial?
"That is accurate. Clinicaltrials.gov lists this study as currently recruiting, with 40 participants needed from 8 different sites. The trial was initially posted on May 30th, 2022 and last updated on July 14th, 2022."
Answered by AI
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