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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.

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 the subacromial balloon spacer safe for treating rotator cuff tears?

The subacromial balloon spacer, used for treating massive irreparable rotator cuff tears, has shown significant improvement in shoulder function and high patient satisfaction with limited need for additional surgery. It is made of a biodegradable material that is expected to fully dissolve within 12 months, and studies have reported positive safety outcomes in humans. ^{1 2 3 4 5}

How is the treatment for rotator cuff tears using a balloon spacer or tuberoplasty different from other treatments?

The balloon spacer and tuberoplasty treatment for rotator cuff tears is unique because it involves inserting a balloon-like device into the shoulder to create space and reduce friction, which is different from traditional surgical repairs that directly stitch or reattach the torn tendons. ^{6 7 8 9 10}

Research Team

Allison Rao

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Subacromial spacer placement for protection of rotator cuff repair. [2022]

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

Subacromial Balloon Spacer for Massive Irreparable Rotator Cuff Tears. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Subacromial Balloon Implantation for the Treatment of Irreparable Posterosuperior Rotator Cuff Tears. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparison between traditional and small-diameter tube-assisted bronchoscopic balloon dilatation in the treatment of benign tracheal stenosis. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Intermediate-Term Outcomes of Slide Tracheoplasty in Pediatric Patients With Ring-Sling Complex. [2022]

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

Single-port robotic transcervical long-segment thoracic tracheal reconstruction: Cadaveric proof-of-concept study. [2022]

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

Transmural rupture and cartilage ring fracture in a tracheobronchial tuberculosis patient. [2023]

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

Balloon dilation causing tracheal rupture: Endoscopic management and literature review. [2018]