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Demineralized Bone Matrix for Rotator Cuff Injury
N/A
Waitlist Available
Research Sponsored by Arthrex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Amenable to double-row repair
Two tendon tear or tear size equal to or greater than 3cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretreatment, 24 weeks, 1 year, 2 year and 5 year
Awards & highlights
Study Summary
This trial found that patients who had demineralized bone matrix augmentation surgery along with their rotator cuff repair had improved tendon healing compared to those who just had rotator cuff repair surgery.
Who is the study for?
This trial is for adults aged 40-75 with primary rotator cuff tears, planning to undergo arthroscopic surgery. Eligible participants have a two-tendon tear or one larger than 3cm and are candidates for bone matrix augmentation. Exclusions include certain severe tendon tears, less than 2mm joint space in the shoulder, previous surgeries or instability, unwillingness to consent, objection to allograft use, outdated MRI scans, pregnancy during the study period, worker's compensation cases and irreparable tears.Check my eligibility
What is being tested?
The trial tests if using demineralized bone matrix during rotator cuff repair surgery improves tendon healing. Participants will receive this treatment as an augmentation during their scheduled arthroscopic surgery aimed at repairing torn tendons in the shoulder.See study design
What are the potential side effects?
While specific side effects of demineralized bone matrix are not listed here, similar treatments may cause local reactions at the surgical site such as pain or swelling; there could also be risks associated with graft materials including infection or immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for a specific type of surgical repair.
Select...
I have a tendon tear that is 3cm or larger, or I have two torn tendons.
Select...
I am scheduled for surgery to repair a complete tear in my shoulder's rotator cuff.
Select...
I have a tear in my shoulder's rotator cuff, possibly with additional tears.
Select...
I am between 40 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pretreatment, 24 weeks, 1 year, 2 year and 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretreatment, 24 weeks, 1 year, 2 year and 5 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRI
Secondary outcome measures
Elbow
Single Assessment Numerical Evaluation (SANE)
Veterans RAND Health (VR-12)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interpositional GroupExperimental Treatment1 Intervention
Demineralized bone matrix
Group II: ControlActive Control1 Intervention
Without demineralized bone matrix
Find a Location
Who is running the clinical trial?
Arthrex, Inc.Lead Sponsor
44 Previous Clinical Trials
29,782 Total Patients Enrolled
5 Trials studying Rotator Cuff Tears
653 Patients Enrolled for Rotator Cuff Tears
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe tear in my shoulder tendon.My shoulder frequently dislocates or feels unstable.I am a candidate for a specific type of surgical repair.I have not had steroid injections in my joints within the last month.I have a tendon tear that is 3cm or larger, or I have two torn tendons.I am scheduled for surgery to repair a complete tear in my shoulder's rotator cuff.I have a tear in my shoulder's rotator cuff, possibly with additional tears.I am between 40 and 75 years old.I do not want to use donor tissue for my treatment.I have a shoulder injury that cannot be surgically repaired.
Research Study Groups:
This trial has the following groups:- Group 1: Interpositional Group
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor include individuals over the age of fifty?
"According to the specifications of this medical trial, individuals aged 40-75 are eligible. Furthermore, there is an additional 10 trials for minors and 94 clinical trials available for elderly patients over 65 years old."
Answered by AI
What are the requirements for participation in this research trial?
"Qualified applicants must have rotator cuff tears and be between 40 to 75 years old. The trial is aiming to include approximately 100 individuals in its cohort."
Answered by AI
Is this research endeavor currently enrolling participants?
"Clinicaltrials.gov has verified that this medical trial is not actively recruiting any participants, despite the fact it was initially published on September 1st 2019 and last edited July 30th 2021. However, there are presently 105 other trials looking for volunteers."
Answered by AI
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