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

Trial Summary

What is the purpose of this trial?

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral 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 data supports the effectiveness of the treatment Augmented Glenoid Component Implantation for shoulder osteoarthritis?

Research suggests that augmented glenoid components can help correct bone loss and improve outcomes in shoulder surgeries, particularly for complex cases with bone defects. These components have shown short-term success in managing glenoid retroversion (a backward tilt of the shoulder socket) and preserving bone, although long-term results are still unknown. ^{1 2 3 4 5}

Is the shoulder surgery technique for osteoarthritis safe?

The safety of shoulder surgery techniques like augmented glenoid implants and bone grafting is still being studied. Short-term results show success, but there is no clear evidence of one method being better than another, and long-term safety is not fully known. Some techniques, like eccentric reaming, may risk bone damage, while bone grafting can be complex and may fail if the graft doesn't heal properly. ^{1 3 6 7 8}

What makes the treatment for shoulder osteoarthritis using Augmented Glenoid Component Implantation and Eccentric Reaming unique?

This treatment is unique because it uses augmented glenoid components to correct bone loss and preserve bone, which can improve long-term performance and provide a simpler, cost-effective option compared to traditional methods like bone grafting. It addresses severe glenoid defects by using innovative techniques that maintain the joint's natural structure. ^{1 2 4 9 10}

Research Team

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Bone Grafting the Glenoid Versus Use of Augmented Glenoid Baseplates with Reverse Shoulder Arthroplasty. [2015]

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

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

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

Augmented glenoid implants in anatomic total shoulder arthroplasty: review of available implants and current literature. [2019]

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

The effect of glenohumeral radial mismatch on different augmented total shoulder arthroplasty glenoid designs: a finite element analysis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

3D fluoroscopic navigated reaming of the glenoid for total shoulder arthroplasty (TSA). [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The subchondral bone layer and glenoid implant design are relevant for primary stability in glenoid arthroplasty. [2018]

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

Reverse Shoulder Arthroplasty Augments for Glenoid Wear. Comparison of Posterior Augments to Superior Augments. [2022]

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

Vault perforation after eccentric glenoid reaming for deformity correction in anatomic total shoulder arthroplasty. [2020]

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

Early results of augmented anatomic glenoid components. [2019]

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

Guidelines for the selection of optimal glenoid augment size for moderate to severe glenohumeral osteoarthritis. [2018]