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New treatment option for Rotator Cuff Tears
Official title InSpace Accelerated Rehabilitation Study
ClinicalTrials.gov ID: NCT05329584
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- people MUST meet ALL the following criteria to be included in the study:
- The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
- Is male or female ≥ sixty-five (65) years of age
- Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT:
- Measuring ≥ 5 cm in diameter
You likely can't join if
- people will be excluded from the study, if they meet ANY of the following individual exclusion criteria:
- Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
- Evidence of the following conditions:
- Severe gleno-humeral or acromio-humeral arthritis
- Full thickness cartilage loss as seen on MRI
- History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic...
See the full eligibility criteria
- people MUST meet ALL the following criteria to be included in the study:
- The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
- Is male or female ≥ sixty-five (65) years of age
- Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT:
- Measuring ≥ 5 cm in diameter
- Involving ≥ two tendons
- Functional deltoid muscle and preserved passive range of motion on physical examination
- Documented VAS score \> 30 mm pain
- Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following:
- Oral analgesics
- Anti-inflammatory medication (e.g., ibuprofen, naproxen)
- Corticosteroid injection(s)
- Physical therapy
- Activity modification
- Rest (sling used)
- 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
- Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection Intra-operative people MUST meet the following criteria to be assigned by chance in the...
- Full thickness tear
- Tear size ≥ 5 cm in diameter
- Tear involving ≥ two tendons
- people will be excluded from the study, if they meet ANY of the following individual exclusion criteria:
- Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
- Evidence of the following conditions:
- Severe gleno-humeral or acromio-humeral arthritis
- Full thickness cartilage loss as seen on MRI
- History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
- Pre-existing deltoid defect or deltoid palsy
- Major joint trauma, infection, or necrosis
- Partial thickness tears of the supraspinatus
- Fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired]
- Known neurovascular compromise
- Complete deltoid muscle palsy
- Traumatic muscle tears of the pectoralis or deltoid
- 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...
- 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 Intra-operative Exclusion Criteria: people will not be assigned by chance and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion...
- Rotator cuff is/presents with:
- Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2)
- Partial thickness tear of the supraspinatus
- Evidence of significant osteoarthritis
- The subject requires concomitant:
- Subscapularis repair
- Labral repair of any type
- Biceps tenodesis
- Coracoacromial ligament functional deficiency or shoulder instability is identified
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Englewood, Colorado, United States
- Fort Lauderdale, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Englewood, Colorado, United States; Fort Lauderdale, Florida, United States; West Palm Beach, Florida, United States; Atlanta, Georgia, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.