Is NCT05329584 recruiting in Little Rock, AR?

Yes, NCT05329584 is currently recruiting participants at its Little Rock, AR location. This rotator cuff tears clinical trial is actively enrolling qualified participants.

How do I join the rotator cuff tears clinical trial in Little Rock?

To join this clinical trial in Little Rock, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Little Rock clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Rotator Cuff Tears Clinical Trial in Little Rock, AR

About This Rotator Cuff Tears Study in Little Rock

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.

Sponsor: Stryker Endoscopy

Who Can Participate

Inclusion Criteria

Subjects 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 Inclusion Criteria Subjects MUST meet the following criteria to be randomized in the study:

Full thickness tear

Tear size ≥ 5 cm in diameter

Tear involving ≥ two tendons

Exclusion Criteria

Subjects 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 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 Intra-operative Exclusion Criteria: Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria:

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Little Rock?

Yes, this clinical trial (NCT05329584) has an active research site in Little Rock, AR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rotator Cuff Tears Treatment Options in Little Rock, AR

If you're searching for rotator cuff tears treatment options in Little Rock, AR, this clinical trial (NCT05329584) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Little Rock research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rotator cuff tears specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rotator cuff tears clinical trials near you to find additional studies recruiting in your area.

Rotator Cuff Tears Clinical Trial in Little Rock, AR

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