Germantown, TNNCT06741527Now EnrollingIRB Ready

Rotator Cuff Tear Clinical Trial in Germantown, TN

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

Sponsored by Anika Therapeutics, Inc.

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Expert Care in Germantown

Access rotator cuff tear specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related rotator cuff tear treatment provided free

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Check if you qualify for this rotator cuff tear clinical trial in Germantown, TN

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Why Participate?

  • No-Cost Study Care

  • Local to Germantown

    Convenient for TN 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 Germantown site if eligible
  4. 4Begin participation

About This Rotator Cuff Tear Study in Germantown

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Sponsor: Anika Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

At least 18 years of age
Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
Fully understands study requirements and able to return for all required follow-up visits and assessments.
Able to comply with all post-operative physician prescribed rehabilitation instructions.
Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: Index shoulder rotator cuff tendon tear needs management and protection from injury Index shoulder has no substantial loss of tendon tissue Index shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack Index shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple Exclusion Criteria The subject exclusion criteria are as follows:
Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
Pregnant, breastfeeding, or plans to become pregnant during the study
History of poor compliance with medical treatment of any kind
Deemed contraindicated for MRI by the PI
Previous rotator cuff surgery (any type) on the index shoulder
Current instability of the index shoulder
Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm)
Chondromalacia of index shoulder ≥ Grade 3
Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
Insulin dependent Type I Diabetes
History of heavy smoking (≥ 1 pack per day) within last 6-months
History of auto-immune or immunodeficiency disorders
Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
History of cognitive or mental health status that interferes with study participation
Poor comprehension of English language
Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: 18.1 Rotator cuff tendon tear is deemed irreparable by the PI 18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon 18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue 18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement 18.5 Presence of infection 18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period 18.7 Hypersensitivity to any of the Integrity Implant System components 18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation 18.9 Inadequate quality of bone for Integrity Bone Staple fixation

Exclusion Criteria

The subject exclusion criteria are as follows:
Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
Pregnant, breastfeeding, or plans to become pregnant during the study
History of poor compliance with medical treatment of any kind
Deemed contraindicated for MRI by the PI
Previous rotator cuff surgery (any type) on the index shoulder
Current instability of the index shoulder
Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm)
Chondromalacia of index shoulder ≥ Grade 3
Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
Insulin dependent Type I Diabetes
History of heavy smoking (≥ 1 pack per day) within last 6-months
History of auto-immune or immunodeficiency disorders
Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
History of cognitive or mental health status that interferes with study participation
Poor comprehension of English language
Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include: 18.1 Rotator cuff tendon tear is deemed irreparable by the PI 18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon 18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue 18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement 18.5 Presence of infection 18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period 18.7 Hypersensitivity to any of the Integrity Implant System components 18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation 18.9 Inadequate quality of bone for Integrity Bone Staple fixation

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 Germantown?

Yes, this clinical trial (NCT06741527) has an active research site in Germantown, TN 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 Tear Treatment Options in Germantown, TN

If you're searching for rotator cuff tear treatment options in Germantown, TN, this clinical trial (NCT06741527) 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 Germantown research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rotator cuff tear 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 tear clinical trials near you to find additional studies recruiting in your area.

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