Reverse vs Anatomic Shoulder Replacement for Shoulder Osteoarthritis

(CERVASA Trial)

Recruiting at 7 trial locations

Overseen By Ailar Ramadi, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Infection, Rotator cuff arthropathy, Paralysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate post-operative care

40 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Reverse Total Shoulder Arthroplasty (RTSA) for shoulder osteoarthritis?

Research shows that both reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA) are effective in relieving pain and restoring shoulder mobility in patients with shoulder arthritis. RTSA is also used successfully as a revision procedure when TSA fails, indicating its effectiveness in complex cases. ^{1 2 3 4 5}

Is reverse total shoulder arthroplasty (RTSA) safe compared to anatomic total shoulder arthroplasty (TSA)?

Both reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA) are common procedures for shoulder issues, but RTSA has variable complication rates and outcomes. There is limited data directly comparing the complication rates between the two procedures. ^{1 2 4 5 6}

How does reverse total shoulder arthroplasty (RTSA) differ from anatomic total shoulder arthroplasty (TSA) for treating shoulder osteoarthritis?

Reverse total shoulder arthroplasty (RTSA) is unique because it can be used for patients who are not candidates for anatomic total shoulder arthroplasty (TSA) or have failed previous TSA, especially when there is a massive irreparable rotator cuff tear. RTSA allows for conversion from TSA without removing well-fixed components, making it a less invasive option for revisions. ^{1 2 4 5 7}

What is the purpose of this trial?

Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)". Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.

Eligibility Criteria

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.

Inclusion Criteria

I am undergoing physiotherapy with exercises and treatments like ultrasound.

My shoulder socket has a deficiency and is tilted backward more than 15 degrees.

I still have pain and disability after 6 months of standard treatment without surgery.

Exclusion Criteria

You have a mental health condition that affects your ability to understand and make informed decisions.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Evaluation

Baseline measurements of shoulder range of motion, strength, and quality of life questionnaires are collected

1 week

1 visit (in-person)

Treatment

Participants undergo either Total Shoulder Arthroplasty (TSA) or Reverse Total Shoulder Arthroplasty (RTSA)

Surgery and immediate post-operative care

1 visit (in-person)

Post-operative Evaluation

Post-operative evaluations at 6 weeks, 3, 6, and 12 months to assess shoulder function and quality of life

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Reverse Total Shoulder Arthroplasty (RTSA)
• Total Shoulder Arthroplasty (TSA)

Trial Overview 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.

Participant Groups

Group I: Reverse Total Shoulder Arthroplasty (RTSA) Experimental Treatment 1 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 Control 1 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.

Reverse Total Shoulder Arthroplasty (RTSA) is already approved in European Union, United States for the following indications:

Approved in European Union as Reverse Total Shoulder Arthroplasty for:

• Rotator cuff tear arthropathy
• Severe irreparable rotator cuff tears
• Shoulder osteoarthritis with severe bone loss
• Proximal humerus fractures
• Chronic shoulder dislocations
• Tumors of the shoulder joint

Approved in United States as Reverse Total Shoulder Replacement for:

• Rotator cuff tear arthropathy
• Severe irreparable rotator cuff tears
• Shoulder osteoarthritis with severe bone loss
• Proximal humerus fractures
• Chronic shoulder dislocations
• Failed anatomical total shoulder arthroplasty

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University Hospital Foundation

Collaborator

Trials

8

Recruited

1,800+

Canadian Orthopaedic Foundation

Collaborator

Trials

15

Recruited

1,900+

Findings from Research

In a study comparing 47 patients undergoing total shoulder arthroplasty (TSA) and 53 patients undergoing reverse total shoulder arthroplasty (RTSA), both procedures showed similar rates of major complications (15% for TSA and 13% for RTSA) and need for revision surgeries (11% for TSA and 9% for RTSA) after an average follow-up of over 2 years.

While both procedures resulted in comparable patient-reported outcomes and range of motion, TSA patients exhibited significantly greater external rotation (53°) compared to RTSA patients (38°), indicating a potential functional advantage for TSA in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. Kiet, TK., Feeley, BT., Naimark, M., et al.[2022]

Reverse total shoulder arthroplasty (RTSA) significantly improves pain, function, and quality of life in patients with failed anatomic total shoulder arthroplasty (TSA), as shown in a study of 75 patients over an average follow-up of 22.3 months.

Despite these improvements, the range of motion and patient-reported outcomes after RTSA do not reach the levels seen in patients undergoing primary RTSA, indicating that while RTSA is beneficial, it may not fully restore function compared to initial surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage reverse total shoulder arthroplasty for failed anatomic total shoulder arthroplasty: a cohort analysis. Otte, RS., Naylor, AJ., Blanchard, KN., et al.[2020]

Patients undergoing total shoulder arthroplasty (TSA) experience a more consistent and effective recovery in pain and function compared to those receiving reverse shoulder arthroplasty (RSA), with TSA patients reaching a plateau in improvement by 6 months.

Both TSA and RSA provide rapid pain relief, but TSA patients achieve 90% to 100% of functional improvement by 6 months, while RSA patients only reach 72% to 91%, indicating TSA may be the preferred option for quicker recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. Levy, JC., Everding, NG., Gil, CC., et al.[2022]

This case series reports a previously unrecognized complication of humeral tray-taper failure in patients who underwent modular reverse total shoulder arthroplasty (RTSA), with five patients experiencing this issue out of 300 total cases over seven years.

Dynamic fluoroscopy was effective in diagnosing the failure, and all patients who underwent revision surgery to a second-generation humeral tray experienced symptom relief, indicating that while the complication is serious, effective treatment options are available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humeral Tray-Taper Failure in Modular Reverse Total Shoulder Arthroplasty. McDonald, LS., Dines, JS., Chin, C., et al.[2020]

In a study of 36 patients who underwent shoulder arthroplasty, both total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA) showed similar patterns of shoulder motion, with no significant differences in motion frequency between the two procedures.

Most shoulder movements occurred below 80° of elevation, with TSA patients averaging 821 motions per hour and RTSA patients averaging 783 motions per hour, indicating that both procedures effectively restore shoulder function without significant differences in performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing daily shoulder motion and frequency after anatomic and reverse shoulder arthroplasty. Langohr, GDG., Haverstock, JP., Johnson, JA., et al.[2018]

In a study of 19,497 patients, those undergoing reverse total shoulder arthroplasty (RTSA) experienced significantly higher rates of perioperative complications, including mortality, pneumonia, and deep venous thrombosis, compared to those who had total shoulder arthroplasty (TSA).

RTSA patients also had longer hospital stays and higher hospital charges, with an average increase of $11,530, indicating that RTSA may carry greater risks and costs than TSA, even after adjusting for patient comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of perioperative complications in patients after total shoulder arthroplasty and reverse total shoulder arthroplasty. Jiang, JJ., Toor, AS., Shi, LL., et al.[2022]

Reverse total shoulder arthroplasty (rTSA) is an effective revision option for patients with failed anatomic total shoulder arthroplasty (TSA) complicated by massive irreparable rotator cuff tears.

Successful rTSA requires careful consideration of glenoid and humeral bone availability, as well as soft-tissue tension, to ensure implant stability and optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision Reverse Total Shoulder Arthroplasty for Failed Anatomic Total Shoulder Arthroplasty With Massive Irreparable Rotator Cuff Tear. Ganokroj, P., Preuss, FR., Peebles, AM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Salvage reverse total shoulder arthroplasty for failed anatomic total shoulder arthroplasty: a cohort analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Humeral Tray-Taper Failure in Modular Reverse Total Shoulder Arthroplasty. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing daily shoulder motion and frequency after anatomic and reverse shoulder arthroplasty. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of perioperative complications in patients after total shoulder arthroplasty and reverse total shoulder arthroplasty. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Revision Reverse Total Shoulder Arthroplasty for Failed Anatomic Total Shoulder Arthroplasty With Massive Irreparable Rotator Cuff Tear. [2023]