Accelerated Rehabilitation for Rotator Cuff Tears

(iAccelerate Trial)

Recruiting at11 trial locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stryker Endoscopy

Must not be taking: Narcotic pain medication

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.

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 data supports the effectiveness of the treatment InSpace Subacromial Tissue Spacer for rotator cuff tears?

Research shows that the InSpace biodegradable balloon spacer can help improve shoulder function and reduce pain in patients with massive irreparable rotator cuff tears by allowing smooth movement in the shoulder joint. It is considered a feasible and safe option, especially for those who cannot undergo more invasive surgeries. ^{1 2 3 4 5}

Is the InSpace Balloon Implant safe for humans?

The InSpace Balloon Implant has been studied for treating rotator cuff tears, and research shows it is generally safe for humans. Studies have confirmed its feasibility and safety profile, with no major safety concerns reported in patients with massive irreparable rotator cuff tears. ^{1 2 4 5 6}

How does the InSpace Subacromial Tissue Spacer treatment differ from other treatments for rotator cuff tears?

The InSpace Subacromial Tissue Spacer is unique because it is a biodegradable balloon implanted between the shoulder bones to allow smooth movement, and it can be inserted using a simple procedure with local anesthesia, making it suitable for patients who cannot undergo more invasive surgeries. ^{1 2 3 4 7}

Research Team

Colleen Roden, MS

Principal Investigator

Stryker Endoscopy

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• InSpace Subacromial Tissue Spacer (Device)

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.

Participant Groups

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)

Who Is Running the Clinical Trial?

Stryker Endoscopy

Lead Sponsor

Trials

5

Recruited

2,000+

Findings from Research

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 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Fluoroscopy-guided implantation of subacromial "biodegradable spacer" using local anesthesia in patients with irreparable rotator cuff tear. [2022]

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

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

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

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

6. India pubmed.ncbi.nlm.nih.gov

The use of a subacromial spacer-inspace balloon in managing patients with irreparable rotator cuff tears. [2022]

7. Spain 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. [2022]