Personalized Instrument for Total Shoulder Arthroplasty

(PITSA Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a personalized guide assists during shoulder replacement surgery for individuals with shoulder osteoarthritis or bone death (AVN). The focus is on improving the precision of placing the glenoid component, a key part of the shoulder joint. Participants will undergo surgery using either traditional methods or a new customized guide created from a 3D CT scan. The study seeks to determine if the personalized guide can enhance surgical accuracy and reduce complications. Individuals with shoulder osteoarthritis or AVN who have not had previous shoulder surgery with metal implants may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative surgical techniques that could improve precision and outcomes for future patients.

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 prior data suggests that this personalized guide is safe for total shoulder arthroplasty?

Research shows that personalized guides for shoulder replacement surgery are safe and effective. Past studies have demonstrated good results and few complications, indicating that patients generally tolerate them well during total shoulder replacement surgery.

The Blueprint 3D planning software, used in both total and reverse shoulder replacement surgeries, has proven effective in several studies. It employs 3D planning before surgery to enhance the surgeon's preparation. This approach aims to increase surgical precision, reducing the risk of issues like incorrect placement of the shoulder implant.

Although long-term data is not yet available, early and midterm results for reverse shoulder replacement using this technology have been positive. No evidence suggests more complications with these personalized guides compared to standard methods.

Overall, current research indicates that using these personalized guides in shoulder surgery is safe. However, as with any medical treatment, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these trials because they explore personalized approaches to shoulder arthroplasty, specifically using the Blueprint software. Unlike standard procedures that rely on generic guides and a 2D CT scan evaluation, the Blueprint software allows for the creation of personalized guides based on detailed 3D CT-scan measurements. This could enhance surgical precision for both total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA), potentially leading to better patient outcomes. By tailoring the surgical instruments to each patient’s unique anatomy, the trials aim to improve the fit and function of shoulder replacements, which is a significant advancement over current standard methods.

What evidence suggests that this trial's personalized guides for shoulder arthroplasty could be effective?

Research has shown that personalized guides, like those used in the TSA Blueprint arm of this trial, can improve implant accuracy during total shoulder replacement surgery. This method employs 3D-printed guides created from detailed CT scans, which has proven to enhance surgical precision. Studies have found that this can lead to better outcomes, including less pain and improved shoulder movement.

For the RTSA Blueprint arm, used in reverse total shoulder replacement, strong evidence supports its effectiveness. Long-term studies have demonstrated that this method can significantly improve shoulder movement and reduce pain. Patients who underwent RTSA reported lasting benefits and improved outcomes from the procedure. ^{1 6 7 8 9}

Who Is on the Research Team?

Dominique Rouleau, MD

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039979/

Long-Term Outcomes Following Reverse Total Shoulder ... RTSA appears to provide substantial long-term improvements in shoulder function, clinical outcomes, and pain relief, albeit with significant complication and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X23000826

Outcomes for reverse total shoulder arthroplasty patients at ... rTSA is proving to be a sustainable procedure for patients with regards to pain, shoulder functionality, and implant survival.

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00960-1/fulltext

Radiological outcome in reverse shoulder arthroplasty ... This study confirms rTSA's effectiveness in reducing pain and improving daily function, with a high readiness among patients to undergo the ...

4. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00075-1/fulltext

Reverse total shoulder arthroplasty in younger patients As newer models and techniques are developed, there is a slow emergence of long-term outcome data favoring the use of rTSA in younger patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7683196/

Clinical Outcomes after Reverse Total Shoulder ... described a 10-year survival rate of 89% after RTSA in 484 shoulders with cuff tear arthropathy in a multicenter study that included revision ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36690174/

Accuracy of Blueprint software in predicting range ... In its current state, preoperative Blueprint 3-dimensional computed tomography planning software is unable to accurately predict ROM 1 year after RTSA.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274624003574

Shoulder Lateralization of the humerus in reverse total ... A lateralized change-in-arm-position did not result in increased overall complications and was protective against postoperative instability.

8. exac.com exac.com/wp-content/uploads/2025/02/12-0004705_Rev_A_GPS_Shoulder_Planning_Research_Booklet_Web.pdf

PEER-REVIEWED PUBLISHED DATA ON GPS SHOULDER We compared the 2-year clinical outcomes of both anatomic and reverse total shoulder arthroplasty (ATSA and RTSA) using intraoperative navigation compared to ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1045452723000366

Measurement of lateralization and distalization in ... The aim of this study was to measure, compare, and classify LO and DO and to assess the effects of modular changes using 2 humeral RTSA implants.