Shoulder Surgery Techniques for Shoulder Osteoarthritis

Recruiting at 1 trial location

Overseen By Peter Lapner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Infection, Muscle paralysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: Surgical procedure

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective shoulder surgery technique for treating advanced osteoarthritis, a condition where cartilage deterioration leads to pain and dysfunction. It compares two surgical methods: one using an augmented glenoid component (a type of implant) with eccentric reaming, and another involving bone grafting. Individuals who have tried non-surgical treatments for shoulder arthritis for at least six months without success may be suitable candidates, particularly if they have specific shoulder joint changes known as glenoid retroversion (a rotation of the shoulder socket). As an unphased study, this trial provides patients the chance to contribute to significant research that could enhance surgical outcomes for shoulder osteoarthritis.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the inclusion criteria mention the use of analgesics and non-steroidal anti-inflammatory drugs, it seems likely that continuing these medications might be allowed.

What prior data suggests that these shoulder surgery techniques are safe?

Previous studies using an enhanced shoulder implant showed promising results. Most patients experienced good to excellent outcomes in the short to mid-term. However, information on its long-term safety remains limited. Complications were relatively uncommon, with about 7.5% of patients experiencing issues.

Reshaping the shoulder socket involves some risk. While generally safe, excessive reshaping can cause the socket to move inward, potentially affecting joint function. Overall, both treatments have been used safely, but each carries its own risks. Considering the benefits and potential complications is important when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Shoulder Surgery Techniques for Shoulder Osteoarthritis because it explores two innovative approaches: Augmented Glenoid Component Implantation and Eccentric Reaming. Unlike traditional shoulder replacements, which may not fully address complex glenoid retroversion, Augmented Glenoid Component Implantation aims to improve joint alignment by using a specialized implant. Eccentric Reaming, on the other hand, reshapes the bone more precisely, potentially enhancing stability and longevity of the shoulder joint. These techniques could offer better outcomes for patients with varying degrees of glenoid retroversion, addressing gaps that current surgical options may leave.

What evidence suggests that these surgical techniques could be effective for shoulder osteoarthritis?

Research has shown that using an enhanced glenoid component in shoulder replacement surgery leads to good to excellent results, particularly for patients with specific shoulder bone issues. Studies have found that patients often experience positive outcomes in the short to mid-term after this surgery. In this trial, participants with 10-15 degrees of glenoid retroversion will receive one treatment approach, while those with more than 15 degrees will receive another. For reshaping the shoulder joint, studies suggest it effectively improves joint alignment, especially in reverse shoulder replacement. Early findings indicate a better range of motion and a low risk of component failure. Both techniques offer promising ways to treat shoulder arthritis with bone loss, although direct comparisons remain limited. ^{1 2 3 4 6}

Who Is on the Research Team?

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with shoulder osteoarthritis who haven't improved after 6 months of non-surgical treatments like painkillers, lifestyle changes, and physiotherapy. Candidates should have specific degrees of bone erosion in their shoulder socket but can't join if they've had previous shoulder surgery on the affected side, certain other joint diseases or infections, severe medical conditions, or are pregnant.

Inclusion Criteria

I have severe shoulder arthritis.

My scans show severe cartilage loss in my shoulder.

Glenoid retroversion between 10-26 degrees

Exclusion Criteria

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

I have significant muscle weakness or paralysis.

I have shoulder joint damage due to rotator cuff issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total shoulder arthroplasty with either eccentric glenoid reaming or augmented glenoid component implantation, or posterior glenoid bone grafting based on their degree of glenoid retroversion

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments including WOOS, Constant Score, ASES, and EQ-5D-5L at multiple intervals

24 months

Visits at 3, 6, 12, and 24 months post-operative

Long-term Follow-up

Participants are monitored for long-term outcomes including component survivorship, quality of life, and adverse events

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Glenoid Component Implantation
• Eccentric Reaming
• Posterior Glenoid Bone Grafting

Trial Overview The study compares two surgical techniques for advanced shoulder osteoarthritis: one involves implanting a special component and removing some bone from the front of the socket (eccentric reaming), while the other combines this component with a bone graft. The goal is to see which method gives better results.

How Is the Trial Designed?

Group I: Participants with 10-15 degrees of glenoid retroversion Active Control 2 Interventions

Group II: Participants with >15 degrees of glenoid retroversion Active Control 2 Interventions

Augmented Glenoid Component Implantation is already approved in United States, European Union for the following indications:

Approved in United States as Augmented Glenoid Component for:

• Glenohumeral osteoarthritis with glenoid bone erosion

Approved in European Union as Augmented Glenoid Component for:

• Severe glenohumeral osteoarthritis
• Glenoid bone loss

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

The paper outlines four strategies for addressing severe glenoid wear during reverse shoulder arthroplasty, including eccentric reaming, bone grafting, a combination of both, and the use of augmented baseplates, each with its own benefits and limitations.

Reverse shoulder arthroplasty is preferred over anatomic shoulder arthroplasty for severe glenoid defects, particularly because augmented baseplates help preserve the underlying bone while effectively treating various defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing glenoid erosion in reverse total shoulder arthroplasty. Gilot, GJ.[2013]

Preserving the subchondral bone layer during glenoid preparation significantly reduces micromotions between the implant and bone, which is crucial for implant stability, as shown in a biomechanical study using artificial bones (n=15).

Using a glenoid component that adapts to the native anatomy further minimizes micromotions compared to non-adapted designs, highlighting the importance of both bone preservation and proper implant design for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The subchondral bone layer and glenoid implant design are relevant for primary stability in glenoid arthroplasty. Sowa, B., Bochenek, M., Braun, S., et al.[2018]

A novel computer-assisted technique for eccentric reaming of the glenoid in total shoulder arthroplasty (TSA) demonstrated significantly greater accuracy compared to the standard freehand method, achieving a target glenoid version of -9.8° versus -5.1° in cadaveric specimens.

The navigated technique also resulted in a reduced deviation from preoperative planning, suggesting it could enhance surgical outcomes and improve the placement of the glenoid component in shoulder surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D fluoroscopic navigated reaming of the glenoid for total shoulder arthroplasty (TSA). Briem, D., Ruecker, AH., Neumann, J., et al.[2022]

In a study of 80 patients undergoing reverse shoulder arthroplasty (rTSA), both augmented glenoid baseplates and glenoid bone grafts significantly improved pain, range of motion, and functional scores, indicating their effectiveness in addressing large glenoid defects.

The augmented glenoid baseplate group had no complications, while the bone graft group experienced a 14.6% complication rate, including glenoid loosenings and graft failures, suggesting that augmented baseplates may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Grafting the Glenoid Versus Use of Augmented Glenoid Baseplates with Reverse Shoulder Arthroplasty. Jones, RB., Wright, TW., Roche, CP.[2015]

In a study of 39 patients undergoing reverse total shoulder arthroplasty (rTSA) with either a superior augmented baseplate (SAB) or a posterior augmented baseplate (PAB), both groups showed significant improvements in pain and function, indicating the efficacy of these approaches without the need for bone grafting.

The PAB group had better outcomes in terms of shoulder function and lower rates of scapular notching compared to the SAB group, suggesting that the PAB may provide superior support for patients with posterior glenoid wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse Shoulder Arthroplasty Augments for Glenoid Wear. Comparison of Posterior Augments to Superior Augments. Wright, TW., Roche, CP., Wright, L., et al.[2022]

In a study of 74 total shoulder arthroplasties (37 with augmented glenoid components and 37 with standard implants), both groups showed similar improvements in range of motion and patient-reported outcomes after a minimum of 2 years follow-up.

Radiographic outcomes indicated that 54% of augmented glenoids showed implant lucencies, similar to 46% in control shoulders, and reoperation rates were comparable, but the 16° augmentation had a higher failure rate, leading to its discontinuation in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results of augmented anatomic glenoid components. Priddy, M., Zarezadeh, A., Farmer, KW., et al.[2019]

The study found a strong correlation between glenoid retroversion and medialization of the joint line when using augmented glenoid implants, which can help guide surgeons in selecting the appropriate size for patients with glenoid deformities.

For different sizes of augmented glenoids (+3, +5, +7), the range of retroversion that restored the anatomic joint line varied significantly, indicating that the choice of augmentation size should be based on the degree of glenoid retroversion to achieve optimal alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for the selection of optimal glenoid augment size for moderate to severe glenohumeral osteoarthritis. Sabesan, V., Callanan, M., Sharma, V.[2018]

Partial correction of modified Walch B/C-type glenoid deformities during total shoulder arthroplasty can achieve 75% bone-implant contact area (BICA) while significantly reducing the risk of vault perforation compared to complete correction.

In a study analyzing 50 shoulder CT scans, it was found that complete correction led to a higher incidence of vault perforation (26%-54%) compared to partial correction (6%-26%), indicating that a more conservative approach may be safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vault perforation after eccentric glenoid reaming for deformity correction in anatomic total shoulder arthroplasty. Olszewski, A., Ramme, AJ., Maerz, T., et al.[2020]

Posteriorly augmented glenoid components are effective in correcting glenoid retroversion greater than 15°, helping to avoid complications like joint line medialization that can occur with traditional reaming techniques.

Current evidence from short-term studies shows successful outcomes with these augmented implants, but there is no consensus on the best design, and long-term survival rates remain unknown.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented glenoid implants in anatomic total shoulder arthroplasty: review of available implants and current literature. Ghoraishian, M., Abboud, JA., Romeo, AA., et al.[2019]

Both the wedge and step augmented glenoid implant designs provided similar stability for the shoulder joint under conditions of bone loss, indicating that either design could be effective in total shoulder arthroplasty.

However, the step design resulted in higher stress levels on the implant and cement mantle, suggesting potential risks for failure, especially under greater radial mismatches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of glenohumeral radial mismatch on different augmented total shoulder arthroplasty glenoid designs: a finite element analysis. Sabesan, VJ., Lima, DJL., Whaley, JD., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9121292/

Early outcomes of augmented glenoid components in ... Overall, early- to mid-term outcomes following augmented anatomic total shoulder arthroplasty for posterior glenoid deficiency demonstrate good to excellent ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1045452725000859

Glenoid augments and revision risk following reverse and ... Augmented glenoid implant usage in shoulder arthroplasty bone loss cases has increased over the past decade. While safe in the short term, ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/17585732231192991

Outcomes of patients undergoing anatomical total shoulder ... Our review found that patients undergoing a-TSA with augmented glenoid components report good outcomes at short-to-mid-term follow-up.

4. aoj.amegroups.org aoj.amegroups.org/article/view/7970/html

Shoulder arthroplasty in patients with glenohumeral ... The purpose of this article is to highlight our suggested treatment algorithm for glenohumeral OA with glenoid bone loss and intact rotator cuff.

5. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00197-5/fulltext

Augmented vs. standard glenoid baseplate use in reverse ... This systematic review demonstrates similar functional and clinical outcomes with the use of augmented glenoid baseplates to address glenoid ...

6. upload.orthobullets.com upload.orthobullets.com/journalclub/pubmed_central/35599710.pdf

Early outcomes of augmented glenoid components in ... Conclusions: Overall, early- to mid-term outcomes following augmented anatomic total shoulder arthroplasty for posterior glenoid deficiency demonstrate good to ...