Personalized Instrument for Total Shoulder Arthroplasty

(PITSA Trial)

Overseen By Karine Tardif

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Montréal

Disqualifiers: Previous arthroplasty, Inflammatory arthritis, Tumor, others

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

Compensation: Varies

Number of Visits: 4

112 Participants Needed

Trial Summary

What is the purpose of this trial?

Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery. In anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability. In order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use. This method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy. The objective of this study is to evaluate the performance of a patient specific glenoid guide.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Personalized Instrument for Total Shoulder Arthroplasty?

Research shows that reverse total shoulder arthroplasty (RTSA) is effective as a revision procedure for failed anatomic total shoulder arthroplasty (TSA), especially in cases with massive irreparable rotator cuff tears. RTSA allows for reconstruction without removing well-fixed components, making it a less extensive procedure. ^{1 2 3 4 5}

Is shoulder replacement surgery generally safe for humans?

Shoulder replacement surgeries, including both anatomic and reverse total shoulder arthroplasty, are common and generally considered safe, but reverse total shoulder arthroplasty may have variable complication rates and outcomes. ^{1 2 3 4 6}

What makes the Personalized Instrument for Total Shoulder Arthroplasty treatment unique compared to other shoulder replacement options?

This treatment is unique because it uses personalized instruments to perform shoulder arthroplasty, allowing for a more tailored approach to surgery. It also offers the flexibility to convert from an anatomic to a reverse total shoulder arthroplasty without removing well-fixed components, which can simplify revision surgeries. ^{1 2 3 4 5}

Research Team

Dominique Rouleau, MD

Principal Investigator

Université de Montréal

Eligibility Criteria

This trial is for patients with shoulder osteoarthritis and AVN who haven't had previous shoulder replacements or surgeries involving metal implants. Participants must speak English or French, agree to a 2-year follow-up, and have no history of shoulder infections, inflammatory arthritis, or tumors.

Inclusion Criteria

I have shoulder arthritis and bone death.

Exclusion Criteria

I have both inflammatory arthritis and a tumor.

I have had a shoulder infection in the past or have one currently.

I received a graft during surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Assessment

Preoperative status characterized by demographic data, range of motion, quality of life, and functional status. CT Scan and x-rays are collected.

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo total shoulder arthroplasty using either the patient-specific glenoid guide or the classic method.

1 day

1 visit (in-person)

Immediate Postoperative Follow-up

Radiological evaluation to compare the precision of glenoid implantation.

2 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for glenoid fixation and bone loss.

2 years

Periodic visits (in-person)

Treatment Details

Interventions

• RTSA Blueprint
• RTSA standard
• TSA Blueprint
• TSA standard

Trial Overview The study is testing personalized guides against standard methods in total shoulder arthroplasty (shoulder replacement surgery) to see if they improve the precision of implanting the glenoid component, potentially reducing surgery time and complications.

Participant Groups

Group I: TSA blueprint Experimental Treatment 1 Intervention

This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.

Group II: RTSA blueprint Experimental Treatment 1 Intervention

This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.

Group III: TSA Standard Active Control 1 Intervention

This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used

Group IV: RTSA standard Active Control 1 Intervention

This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used

RTSA Blueprint is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as RTSA for:

• Irreparable rotator cuff tears
• Aseptic necrosis of the humeral head
• Revision surgery following failed anatomical or resurfacing arthroplasty

Approved in United States as RTSA for:

• Rotator cuff-deficient shoulders
• Complex fractures
• Degenerative shoulder diseases

Approved in Canada as RTSA for:

• Shoulder arthritis
• Posttraumatic osteoarthritis
• Inflammatory arthropathy

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

Findings from Research

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]

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]

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]

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]

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]

In a study of 740 patients (370 each for aTSA and rTSA) with osteoarthritis and intact rotator cuffs, both surgical approaches showed similar clinical outcomes and patient satisfaction after an average follow-up of 41 months.

However, patients who underwent anatomic total shoulder arthroplasty (aTSA) experienced a higher rate of complications (4.9%) compared to those who had reverse total shoulder arthroplasty (rTSA) (2.2%), suggesting that rTSA may be a safer option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Reverse and Anatomic Total Shoulder Arthroplasty in Patients With an Intact Rotator Cuff and No Previous Surgery. Friedman, RJ., Schoch, BS., Eichinger, JK., et al.[2022]

References

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

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

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

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

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Comparison of Reverse and Anatomic Total Shoulder Arthroplasty in Patients With an Intact Rotator Cuff and No Previous Surgery. [2022]