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Procedure

BioEnthesis for Rotator Cuff Tears

Phase 4

Recruiting

Led By Jonathan Dickens, MD

Research Sponsored by Brooke Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operation at 3-months, 6-months, and 12-months

Awards & highlights

Study Summary

This trial aims to improve the success rate of rotator cuff repairs. The current method involves using suture anchor-based techniques, but this often leads to re-tearing of the connective tissue. A

Who is the study for?

This trial is for individuals with rotator cuff injuries requiring surgery. Ideal candidates are those who have not had success with standard treatments and are looking for an alternative that may improve tendon-bone healing and reduce the chance of re-injury.Check my eligibility

What is being tested?

The MIRROR Project 44 compares two surgical methods for repairing rotator cuff tears: one using a new technique called BioEnthesis augmentation, which aims to better connect tendon to bone, versus traditional repairs without this technology.See study design

What are the potential side effects?

While specific side effects aren't detailed here, typical risks of rotator cuff repair surgeries include infection, nerve damage, pain at the site of surgery, stiffness in the shoulder joint, and potential failure or re-tearing of the repaired tendon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of re-tear

Secondary outcome measures

Change in range of motion measurements from before surgery to after surgery

Change in strength measurements from before surgery to after surgery

Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BioEnthesisExperimental Treatment1 Intervention

Allogenic, acellular, biphasic allograft (BioEnthesis)

Group II: Standard of CareActive Control1 Intervention

Standard rotator cuff repair (suture and anchor based technique)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sparta BiopharmaUNKNOWN

Brooke Army Medical CenterLead Sponsor

119 Previous Clinical Trials

26,459 Total Patients Enrolled

Musculoskeletal Injury Rehabilitation Research for Operational ReadinessFED

3 Previous Clinical Trials

298 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 65 years and above eligible to participate in this recruitment for the clinical trial?

"Individuals aged between 18 and 65 are eligible for participation in this research study. Notably, there are a total of 32 trials focused on participants under the age of 18 and 339 studies targeting individuals over the age of 65."

Answered by AI

Has BioEnthesis received approval from the FDA?

"Given that this trial is in Phase 4 and BioEnthesis has already gained approval, our team rates its safety at the highest level of 3."

Answered by AI

Is the enrollment process currently open for this clinical trial?

"As per information available on clinicaltrials.gov, patient recruitment is ongoing for this trial. It was first listed on 2/1/2024 and last revised on 2/29/2024."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Confirmed by clinicaltrials.gov, the ongoing trial is currently enrolling participants. It was first listed on February 1st, 2024, and last modified on February 29th of the same year. The study aims to recruit a total of 100 individuals from two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Dr. Andrew Sheean 2024. "MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06289686.

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