Pittsburgh, PANCT05444465Now EnrollingIRB Ready

Rotator Cuff Injuries Clinical Trial in Pittsburgh, PA

Access cutting-edge rotator cuff injuries treatment through this clinical trial at a research site in Pittsburgh. Study-provided care at no cost to qualified participants.

Sponsored by Smith & Nephew, Inc.

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Expert Care in Pittsburgh

Access rotator cuff injuries specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related rotator cuff injuries treatment provided free

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Check if you qualify for this rotator cuff injuries clinical trial in Pittsburgh, PA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Pittsburgh

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Pittsburgh site if eligible
  4. 4Begin participation

About This Rotator Cuff Injuries Study in Pittsburgh

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Sponsor: Smith & Nephew, Inc.

Who Can Participate

Inclusion Criteria

The subject must provide written informed consent.
Subject is \> eighteen (18) years of age (no upper limit).
Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
Subject willing and able to make all required study visits.
Subject able to follow instructions and deemed capable of completing all study questionnaires.

Exclusion Criteria

Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
Subjects with current or prior infection of the ipsilateral shoulder.
Subjects with known hypersensitivity to bovine-derived materials.
Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
Subjects with a planned surgery on the contra-lateral shoulder within the study period.
Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
Subjects with a full thickness rotator cuff tear.
Subjects with a subscapularis tear requiring repair.
Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
Subjects requiring a concomitant os acromiale fixation procedure.
Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
Subjects with neurologic conditions effecting either upper extremity.
Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
Subjects who are pregnant or breast feeding.
Subjects who are currently involved in any injury litigation relating to the index shoulder.
Subjects with current workers compensation claim.
Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

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 Pittsburgh?

Yes, this clinical trial (NCT05444465) has an active research site in Pittsburgh, PA 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 Injuries Treatment Options in Pittsburgh, PA

If you're searching for rotator cuff injuries treatment options in Pittsburgh, PA, this clinical trial (NCT05444465) 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 Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rotator cuff injuries 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 injuries clinical trials near you to find additional studies recruiting in your area.

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