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New treatment option for Rotator Cuff Injuries
Official title Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
ClinicalTrials.gov ID: NCT05444465
What this study is testing
- What it's testing
- The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
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
- The subject must provide written informed consent.
- Subject is \> eighteen (18) years of age (no upper limit).
- Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
- Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
- Subject willing and able to make all required study visits.
You likely can't join if
- people with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant...
- people where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
- people with Samilson-Prieto osteoarthritis grade 2 and greater.
- people with current or prior infection of the ipsilateral shoulder.
- people with known hypersensitivity to bovine-derived materials.
- people with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities...
See the full eligibility criteria
- The subject must provide written informed consent.
- Subject is \> eighteen (18) years of age (no upper limit).
- Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
- Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
- Subject willing and able to make all required study visits.
- Subject able to follow instructions and deemed capable of completing all study questionnaires.
- people with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
- people where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
- people with Samilson-Prieto osteoarthritis grade 2 and greater.
- people with current or prior infection of the ipsilateral shoulder.
- people with known hypersensitivity to bovine-derived materials.
- people with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
- people with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
- people with a planned surgery on the contra-lateral shoulder within the study period.
- Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
- people with a full thickness rotator cuff tear.
- people with a subscapularis tear requiring repair.
- people requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
- people requiring a concomitant os acromiale fixation procedure.
- people with glenohumeral joint instability (multiple dislocations/subluxations).
- people with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal...
- people with neurologic conditions effecting either upper extremity.
- people who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
- people who are pregnant or breast feeding.
- people who are currently involved in any injury litigation relating to the index shoulder.
- people with current workers compensation claim.
- people who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
- people with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and...
- people who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- people who have participated previously in this clinical trial and who have healed or been withdrawn
- people with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Georgia, United States
- Rockford, Illinois, United States
- Baltimore, Maryland, United States
- Garfield Heights, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Bedford, Texas, United States
- The Woodlands, Texas, United States
- Ashland, Wisconsin, United States
- Richmond, Victoria, Australia
- Calgary, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Hamilton, Ontario, Canada
- Milan, Italy
- Roma, Italy
- Madrid, Spain
- Chertsey, Surrey, United Kingdom
- Bath, United Kingdom
- Bristol, United Kingdom
- Salford, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Rome, Georgia, United States; Rockford, Illinois, United States; Baltimore, Maryland, United States; Garfield Heights, Ohio, United States; Pittsburgh, Pennsylvania, United States; Bedford, Texas, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.