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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

Must not have

History of previous shoulder surgery on affected side

Unwilling to be followed for the duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3-, 6- and 12-months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My shoulder arthritis hasn't improved with standard treatments, and I need surgery.

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My shoulder joint shows advanced cartilage loss.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had shoulder surgery on the same side as my current condition.

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I am not willing to participate in follow-up visits for the study.

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I have Charcot's joint disease.

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I do not have a major illness that would give me less than a year to live.

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I currently have an infection in my joints or throughout my body.

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I have significant muscle weakness or paralysis.

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I have shoulder joint damage due to rotator cuff issues.

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I need surgery to correct my shoulder joint alignment.

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My joint cannot be corrected to almost straight with surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3-, 6- and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)

Secondary study objectives

Change in Constant Score

Change in EuroQol EQ-5D-5L quality of life questionnaire

Change in Shoulder Pain

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met