Tuberoplasty vs Balloon Spacer for Rotator Cuff Tears

Overseen By Allison Rao

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Minnesota

Disqualifiers: Subscapularis involvement, Acromiohumeral distance < 7 mm, Repairable rotator cuff, Age < 65, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for individuals with severe shoulder issues due to massive rotator cuff tears, involving muscles like the supraspinatus and infraspinatus. Researchers aim to determine which method—tuberoplasty (where a graft aids bone contact) or a balloon spacer (the InSpace subacromial balloon spacer)—better reduces pain and improves shoulder movement. Special imaging will assess shoulder movement before and after treatment. This trial suits those who have had previous shoulder surgery but still experience pain and have a centered humeral head on an X-ray. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatments work and measuring their effectiveness in an initial group, offering participants a chance to contribute to advancements in shoulder care.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, patients who underwent arthroscopic tuberoplasty for rotator cuff tears experienced less pain and improved shoulder movement. Research has shown that biologic tuberoplasty, which uses a donor skin graft, can lead to good short-term results and aid in rotator cuff healing.

Studies have found that the subacromial balloon spacer is generally safe and can quickly enhance shoulder function and reduce pain. This minimally invasive treatment involves a small procedure to place a balloon in the shoulder, easing pain and improving movement for those with severe rotator cuff tears.

Both treatments are in early-phase trials, meaning they are still being tested for safety and effectiveness. However, early results suggest that both options are generally well-tolerated and show promise in reducing pain and improving shoulder function for patients with rotator cuff tears. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for massive irreparable rotator cuff tears because they offer innovative approaches compared to traditional options like physical therapy, corticosteroid injections, or surgical repair. The biologic tuberoplasty treatment offers a unique surgical method that involves enhancing the bone surface to improve joint mechanics and potentially reduce pain. Meanwhile, the subacromial balloon spacer provides a novel, minimally invasive option by inserting a balloon spacer to create a cushion in the shoulder, which can help reduce friction and improve shoulder movement. Both treatments aim to address pain and improve function without the need for more invasive surgeries, providing hope for better quality of life for patients.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

This trial will compare two treatments for massive irreparable rotator cuff tears: tuberoplasty and the subacromial balloon spacer. Studies have shown that tuberoplasty can greatly reduce pain and improve movement for people with large shoulder tears that can't be repaired. Research indicates that this procedure has a very low chance of recurrence, with some studies showing no repeat tears at all. Meanwhile, the subacromial balloon spacer has significantly improved shoulder function and reduced pain for similar tears. Although it offers moderate satisfaction over time, it remains a promising option for those seeking a less invasive treatment. Both treatments aim to enhance shoulder mobility and reduce pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Allison Rao

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals with a severe rotator cuff injury or tear. Participants should be suitable candidates for shoulder procedures and willing to undergo imaging tests before and after the treatment. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline health conditions that qualify or disqualify someone from participating.

Inclusion Criteria

Centered humeral head on X-ray examination

My main issue is pain.

I have a severe shoulder tear that cannot be repaired.

Exclusion Criteria

Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph

I am under 65 years old.

My subscapularis muscle is affected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either biologic tuberoplasty or subacromial balloon spacer surgery for massive irreparable rotator cuff tears

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in bone-to-bone contact, shoulder range of motion, and shoulder function using various assessments

12 months

Multiple visits at 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Balloon Spacer
• Tuberoplasty

Trial Overview The study compares two treatments for rotator cuff injuries: biologic tuberoplasty versus subacromial balloon spacer. It aims to see which method better reduces bone-to-bone contact in the shoulder using advanced imaging techniques and will also measure patient pain relief and improved shoulder function.

How Is the Trial Designed?

Group I: subacromial balloon spacer group Experimental Treatment 1 Intervention

massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to subacromial balloon spacer.

Group II: biologic tuberoplasty group Experimental Treatment 1 Intervention

massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to biologic tuberoplasty surgery.

Balloon Spacer is already approved in European Union, United States for the following indications:

Approved in European Union as InSpace subacromial balloon spacer for:

• Massive irreparable rotator cuff tears

Approved in United States as InSpace subacromial balloon spacer for:

• Massive irreparable rotator cuff tears

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The InSpace balloon spacer implant showed significant improvements in shoulder function and pain relief compared to partial repair in patients with irreparable rotator cuff tears, with 83% of patients achieving clinically important improvements after 24 months.

The InSpace procedure had a shorter operative time and resulted in greater forward shoulder elevation at multiple follow-up points, indicating a quicker recovery compared to traditional partial repair methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears: A Multicenter, Single-Blinded, Randomized Controlled Trial. Verma, N., Srikumaran, U., Roden, CM., et al.[2022]

The implantation of a biodegradable subacromial balloon spacer (InSpace) is a promising treatment option for irreparable rotator cuff tears (IRCTs), although outcomes have varied due to different indications and techniques used.

This article aims to provide a standardized arthroscopic technique for balloon implantation, which may help improve the consistency and effectiveness of this treatment for IRCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial Balloon Implantation for the Treatment of Irreparable Posterosuperior Rotator Cuff Tears. Marigi, EM., Alder, KD., Morrey, MM., et al.[2023]

The biodegradable subacromial balloon spacer (InSpace) has shown significant clinical benefits for patients with massive irreparable rotator cuff tears (MIRCTs), including improved shoulder function and high patient satisfaction over a mean follow-up of 3 years.

In a recent multicenter randomized controlled trial involving 184 patients, both the balloon spacer and arthroscopic partial repair groups demonstrated significant improvements in shoulder function, indicating that the balloon spacer is an effective treatment option for MIRCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial Balloon Spacer for Massive Irreparable Rotator Cuff Tears. Srikumaran, U., Russo, R., Familiari, F.[2023]

A proof-of-concept study demonstrated that long-segment slide tracheoplasty can be successfully performed using a small neck incision and a single-port robotic surgical system in adult cadavers, suggesting a less invasive approach compared to traditional median sternotomy.

The operative time for this robotic technique was comparable to standard open surgical methods, indicating that it may be a viable alternative, but further research is needed to assess its safety and effectiveness in live patients, especially in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic transcervical long-segment thoracic tracheal reconstruction: Cadaveric proof-of-concept study. Lui, NS., Holsinger, FC., Ma, MR., et al.[2022]

The study reviewed the outcomes of slide tracheoplasty in 78 children with ring-sling complex, finding that the intermediate-term results are satisfactory, with a median follow-up of 2.1 years.

Type 2B patients, who have more severe tracheobronchial anomalies, showed higher rates of complications such as tracheomalacia and restenosis, highlighting the need for careful preoperative assessment and postoperative monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-Term Outcomes of Slide Tracheoplasty in Pediatric Patients With Ring-Sling Complex. Chen, H., Shi, G., Zhu, L., et al.[2022]

In a study of 31 patients with irreparable massive rotator cuff tears, implantation of the InSpace Balloon significantly improved shoulder function and pain levels, with 80.6% of patients reporting high satisfaction after an average follow-up of 22.1 months.

Combining the InSpace Balloon with an arthroscopic partial repair did not show any additional benefits compared to the balloon implantation alone, suggesting that the balloon itself is an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears. Malahias, MA., Brilakis, E., Avramidis, G., et al.[2022]

In a study of 58 patients with benign tracheal stenosis, small-diameter tube-assisted bronchoscopic balloon dilatation (BBD) demonstrated better long-term efficacy compared to traditional BBD, with a success rate of 85.3% versus 59.1%.

The small-diameter tube-assisted method showed improved safety, as there were no significant changes in oxygen saturation during the procedure, unlike the traditional method, which had notable fluctuations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between traditional and small-diameter tube-assisted bronchoscopic balloon dilatation in the treatment of benign tracheal stenosis. Li, LH., Liang, YL., Li, Y., et al.[2018]

The use of a biodegradable subacromial balloon-shaped spacer (InSpace) during rotator cuff repairs may significantly improve repair strength and reduce failure rates by protecting the tendon repair and centering the humeral head.

This spacer is implanted arthroscopically after the rotator cuff repair, and its correct placement is confirmed by ensuring free arm movement, which helps reduce friction and flatten dog-ear formations at the repair site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial spacer placement for protection of rotator cuff repair. Szöllösy, G., Rosso, C., Fogerty, S., et al.[2022]

A 29-year-old female with tuberculosis tracheobronchial stenosis experienced complications from endobronchial balloon dilation, including transmural rupture and cartilage ring fracture, highlighting the risks associated with this treatment.

The patient ultimately recovered after 18 months of conservative management, suggesting that non-invasive approaches may be preferable for treating severe complications in tuberculosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transmural rupture and cartilage ring fracture in a tracheobronchial tuberculosis patient. Wu, G., Chen, Q., Huang, T., et al.[2023]

A 72-year-old woman experienced a tracheal rupture during balloon dilation, but an 80 × 20-mm silicone-covered stent was successfully used to repair the defect, allowing for minimal air escape and a smooth recovery.

The case highlights that while tracheal rupture is a serious risk associated with balloon dilation, endoscopic stenting can be an effective alternative to traditional open repair, leading to successful healing without major complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon dilation causing tracheal rupture: Endoscopic management and literature review. Heyes, R., Cervantes, SS., Matthaeus, J., et al.[2018]

Citations

1. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(22)00652-3/fulltext

Subacromial balloon spacer for irreparable rotator cuff ... We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. Methods. We conducted a double- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10806962/

Subacromial Balloon Spacer for the Massive Irreparable ... The InSpace subacromial balloon spacer is a simple device that can yield substantial improvements in clinical outcomes among a subset of ...

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00782-5/fulltext

The Subacromial Balloon Spacer for Massive Irreparable ... The InSpace subacromial balloon spacer is indicated for the treatment of massive irreparable rotator cuff tears.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324004596

Arthroscopic Subacromial Balloon Spacer for Massive ... Employing a balloon spacer for MRCTs yielded moderate satisfaction at the 5-year follow-up, with stable revision rates within the first 2 years.

5. aoj.amegroups.org aoj.amegroups.org/article/view/5880/html

Balloon spacers in the management of massive rotator cuff ... The subacromial balloon spacer is a novel treatment option allowing for both temporary and definitive treatment for such patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37247776/

Outcomes of subacromial balloon spacer implantation for ... Short-term outcomes suggest that SABS implantation can be a safe and effective treatment and appears to be associated with early improvements in postoperative ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0974322725004880

The subacromial balloon spacer: Adhering to indications ... The subacromial balloon spacer has emerged as a viable treatment option for patients with massive, irreparable rotator cuff tears.

8. stryker.com stryker.com/us/en/sports-medicine/products/inspace.html

InSpace subacromial balloon spacer InSpace is the industry's only minimally invasive biodegradable, subacromial balloon spacer for arthroscopic treatment of massive, irreparable rotator cuff ...