Accelerated Rehabilitation for Rotator Cuff Tears

(iAccelerate Trial)

Recruiting at 11 trial locations

Overseen By Hayley Taylor, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Endoscopy

Must not be taking: Narcotic pain medication

Disqualifiers: Severe arthritis, Deltoid palsy, Major trauma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to aid recovery after receiving an InSpace device for severe rotator cuff tears. The InSpace device, also known as the InSpace Subacromial Tissue Spacer, improves shoulder movement by acting as a cushion in the joint. Participants will either join a formal rehab program or perform exercises at home to determine which method is more effective. It suits individuals with a rotator cuff tear of at least 5 centimeters who have not found relief from other treatments like physical therapy and experience shoulder pain. As an unphased trial, this study provides a unique opportunity to explore personalized recovery options for enhanced shoulder function.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on prescription narcotic pain medication for conditions unrelated to the shoulder issue.

What prior data suggests that the InSpace device is safe for treating rotator cuff tears?

Research has shown that the InSpace Subacromial Tissue Spacer is safe for humans. The FDA has approved the device for treating large, irreparable tears in the shoulder's rotator cuff, confirming it meets specific safety standards for this use. Studies indicate that the InSpace device offers a simple and minimally invasive option that patients handle well. It consists of a biodegradable balloon filled with saltwater, surgically inserted between the shoulder bones. Most patients experience positive results with few short-term side effects, suggesting the treatment is generally well-tolerated and a potentially safe choice for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the InSpace Subacromial Tissue Spacer for rotator cuff tears because it offers a minimally invasive approach compared to the traditional surgeries usually involving sutures or anchors. This device works by creating a physical space to reduce friction in the shoulder, potentially speeding up recovery and reducing pain. Additionally, this trial explores two unique rehabilitation methods: one involving a formalized program and another allowing patients to follow an at-home regimen, which could lead to more personalized and flexible recovery options.

What evidence suggests that the InSpace device is effective for treating rotator cuff tears?

Research has shown that the InSpace subacromial tissue spacer can reduce pain and improve shoulder movement in individuals with large, unfixable rotator cuff tears. A study in The Lancet found that patients using the InSpace balloon experienced less pain and better shoulder movement. This trial will evaluate the InSpace device in two different rehabilitation settings. Group I participants will receive the InSpace device with accelerated rehabilitation in a formalized program, while Group II participants will receive the device with an at-home accelerated rehabilitation program. The spacer is biodegradable and naturally dissolves over time. Early results suggest this treatment can offer promising improvements for those who haven't found relief with other methods. ^{1 3 4 6 7}

Who Is on the Research Team?

Colleen Roden, MS

Principal Investigator

Stryker Endoscopy

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with massive, irreparable rotator cuff tears that are at least 5 cm wide and involve two or more tendons. They must have tried non-surgical treatments like painkillers, anti-inflammatories, steroid injections, physical therapy, or rest without success. Participants need to be in good health overall, able to walk and take care of themselves post-surgery.

Inclusion Criteria

Must be able to read and understand the approved Informed Consent Form (written and oral)

Must be in general good health (as determined by the Investigator) based on screening assessments and medical history

My surgery revealed a tear larger than 5 cm involving two or more tendons.

Exclusion Criteria

Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)

The subject requires concomitant: Subscapularis repair, Labral repair of any type, Biceps tenodesis, Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy, The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder, Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis), The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment, The subject's condition represents a worker's compensation case, The subject is currently involved in a health-related litigation procedure, Females of child-bearing potential who are pregnant or plan to become pregnant, Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period, The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up, The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition, The subject currently has an acute infection in the area surrounding the surgical site, Baseline WORC score less than 420

I have a diagnosed nerve or blood vessel disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an arthroscopic procedure with the InSpace device and participate in either a formalized or at-home accelerated rehabilitation program

12 months

Regular visits as per rehabilitation program

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of clinical outcomes and quality of life

24 months

Follow-up visits at regular intervals

What Are the Treatments Tested in This Trial?

Interventions

• InSpace Subacromial Tissue Spacer

Trial Overview

The study is testing two different accelerated rehabilitation programs after the surgical placement of an InSpace device—a subacromial tissue spacer—during arthroscopy for large rotator cuff tears. It's a randomized trial comparing how patients recover with each program.

How Is the Trial Designed?

Group I: Group II Experimental Treatment 1 Intervention

InSpace device + accelerated rehabilitation in an at-home program (AHP)

Group II: Group I Experimental Treatment 1 Intervention

InSpace device + accelerated rehabilitation in a formalized program (FP)

InSpace Subacromial Tissue Spacer is already approved in United States for the following indications:

Approved in United States as InSpace Subacromial Tissue Spacer for:

• Massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age

Who Is Running the Clinical Trial?

Stryker Endoscopy

Lead Sponsor

Trials

5

Recruited

2,000+

Published Research Related to This Trial

In a study of 30 patients with massive irreparable rotator cuff tears, the implantation of the biodegradable InSpace Balloon® significantly improved shoulder function, as evidenced by an increase in Constant Score from approximately 40 to 65 points over 12 months.

Patients experienced notable reductions in pain and improvements in range of motion and daily activities, indicating that the InSpace Balloon® is an effective surgical option for restoring shoulder function in individuals with severe rotator cuff injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears. Ricci, M., Vecchini, E., Bonfante, E., et al.[2022]

The biodegradable sub-acromial spacer (InSpace™) implantation in 20 patients with massive irreparable rotator cuff tears showed significant improvement in shoulder function over 3 years, with the Constant score increasing from 33.4 to 65.4 points.

The procedure was found to be low-risk and simple, with sustained pain relief and functional improvements in daily activities and motion, indicating its efficacy as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Senekovic, V., Poberaj, B., Kovacic, L., et al.[2022]

The use of a biodegradable subacromial balloon-shaped spacer (InSpace) offers a novel surgical technique for treating massive rotator cuff tears, allowing for improved shoulder biomechanics by enabling smooth gliding between the humeral head and acromion.

This procedure can be performed in an outpatient setting under local anesthesia, making it a safer option for patients with multiple health issues that may complicate traditional surgeries like reverse arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroscopy-guided implantation of subacromial "biodegradable spacer" using local anesthesia in patients with irreparable rotator cuff tear. Gervasi, E., Cautero, E., Dekel, A.[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 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 study involved 14 patients with massive irreparable rotator cuff tears who underwent arthroscopic implantation of a biodegradable subacromial spacer, showing significant improvements in shoulder function and pain relief after a mean follow-up of 12.6 months.

Patients experienced increased range of motion and substantial improvements in Constant and Oxford shoulder scores, indicating that this minimally invasive procedure is effective and safe for elderly patients with irreparable cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a subacromial spacer-inspace balloon in managing patients with irreparable rotator cuff tears. Yallapragada, RK., Apostolopoulos, A., Katsougrakis, I., et al.[2022]

In a study of 25 patients with irreparable rotator cuff tears, the use of a biodegradable subacromial spacer (InSpaceTM) led to significant improvements in shoulder function, with an average increase of 22.9 points in the Constant score after one year (from 32 to 54.9 points).

The majority of patients (87%) reported a reduction in pain, with average pain scores improving from 8.7 to 3.7, and 73% expressed satisfaction with the procedure, indicating that this low-invasive technique can be a viable option for managing severe shoulder injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results after the application of biodegradable spacer balloons as a therapeutic option in non-repairable massive ruptures of the shoulder rotator cuff. García Moreno, J., Correa Bellido, P., Salazar Aguilar, JR., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6794659/

Outcomes of Subacromial Balloon Spacer Implantation for ...

When nonoperative treatment fails, operative management is often indicated to reduce pain, restore shoulder function, and decrease likelihood of ...

2.

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 ...

3.

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10551680/

InSpace Balloon for the Management of Massive ...

Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear. Musculoskelet Surg ...

5.

jshoulderelbow.org

jshoulderelbow.org/article/S1058-2746(23)00392-0/abstract

Outcomes of subacromial balloon spacer implantation for ...

Outcomes of subacromial balloon spacer implantation for irreparable rotator cuff tears: a systematic review and meta-analysis. Alexander N. Berk ...

6.

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 ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN200039.pdf

DEN200039 | FDA

The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons ...