BridgeMD
New treatment option for Rotator Cuff Tears
Official title Bioinductive Patch for Full-Thickness Rotator Cuff Tears
ClinicalTrials.gov ID: NCT05439850
What this study is testing
What is Bioinductive implant?
Bioinductive implant is an investigational medicine, being studied as a potential treatment for rotator cuff tears.
Also referred to as Bioinductive patch.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Indicated and scheduled for arthroscopic rotator cuff repair.
- Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons...
- Chronic, degenerative rotator cuff tears.
- Ability to read and understand English.
- Age ≥18 years
You likely can't join if
- Patient scheduled for open or mini-open rotator cuff repair
- Prior surgery of affected shoulder (except diagnostic arthroscopy)
- Partial-thickness rotator cuff tears
- Small (\<1 cm) rotator cuff tears
- Rotator cuff tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
See the full eligibility criteria
- Indicated and scheduled for arthroscopic rotator cuff repair.
- Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
- Chronic, degenerative rotator cuff tears.
- Ability to read and understand English.
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
- Patient scheduled for open or mini-open rotator cuff repair
- Prior surgery of affected shoulder (except diagnostic arthroscopy)
- Partial-thickness rotator cuff tears
- Small (\<1 cm) rotator cuff tears
- Rotator cuff tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
- Active infection
- Cancer
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.