New Haven, CTNCT05997381Now EnrollingIRB Ready

Rotator Cuff Tears Clinical Trial in New Haven, CT

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

Sponsored by CONMED Corporation

Quick Self-Assessment

See if you qualify for this New Haven location

Preparing your pre-screening questions…

Expert Care in New Haven

Access rotator cuff tears specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related rotator cuff tears treatment provided free

Apply for This New Haven Location

Check if you qualify for this rotator cuff tears clinical trial in New Haven, CT

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT 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 New Haven site if eligible
  4. 4Begin participation

About This Rotator Cuff Tears Study in New Haven

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Sponsor: CONMED Corporation

Who Can Participate

Inclusion Criteria

Male or female 40 to 70 years old
Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
Tear of the supraspinatus and/or infraspinatus tendons
Tear size ≥ 2 cm and \< 5 cm
Chronic shoulder pain ≥ 3 months
Failed non-operative treatment of the index shoulder to include one or all of the following:
Oral analgesics
Nonsteroidal anti-inflammatory medications (NSAIDs)
Corticosteroid injections
Activity modifications
Physical therapy or home-guided exercises
Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
Willing to be available to attend each protocol-required follow-up examination Intraoperative Inclusion Criteria:
Full thickness tear of the supraspinatus and/or infraspinatus tendons
Tear size ≥ 2 cm and \< 5 cm
Able to reapproximate the tendons to cover \> 50% of the footprint on the greater tuberosity

Exclusion Criteria

Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
Oral steroid use or steroid injection within 6 weeks prior to surgery
Active smoker
History of insulin-dependent diabetes
Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
History of claustrophobia that would prevent an MRI of the index shoulder
Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
Currently participating, or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator
History of non-compliance with medical treatment or clinical trial participation
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 with protocol required follow-up
Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
The subject is receiving prescription narcotic pain medication
The subject currently has an acute infection in the area surrounding the surgical site
Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
The subject's condition represents a worker's compensation case Intraoperative Exclusion Criteria: 1\. Subject requires subscapularis repair other than a repair with a single anchor

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 New Haven?

Yes, this clinical trial (NCT05997381) has an active research site in New Haven, CT 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 New Haven, CT

If you're searching for rotator cuff tears treatment options in New Haven, CT, this clinical trial (NCT05997381) 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 New Haven 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.

More Tendinitis Trials in New Haven, CT

See all tendinitis clinical trials recruiting in New Haven — not just this study.

Browse Tendinitis Trials in New Haven →

Browse More Trials by Condition

Tendinitis TrialsAll Conditions →

Ready to Join in New Haven?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · New Haven, CT