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Tests treatment safety and results for Rotator Cuff Tears
Official title Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
ClinicalTrials.gov ID: NCT05894265
What this study is testing
- What it's testing
- The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 1-2 tendon full thickness reparable rotator cuff tendon tear(s) Reparable tear defined as: a tear of the rotator cuff where it is possible to bring...
- Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and...
- Have no contraindications or allergies to the treatment administered
You likely can't join if
- Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior...
- Prior surgery for bone defects requiring bone implantation in the index shoulder,
- Steroid injection into the index shoulder within 6 weeks of enrollment.
- Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
- Calcific tendonitis in the index shoulder,
- Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 1-2 tendon full thickness reparable rotator cuff tendon tear(s) Reparable tear defined as: a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus...
- Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
- Have no contraindications or allergies to the treatment administered
- Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
- Able and willing to comply with the post-operative physical therapy and study follow-up schedule
- Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
- Prior surgery for bone defects requiring bone implantation in the index shoulder,
- Steroid injection into the index shoulder within 6 weeks of enrollment.
- Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
- Calcific tendonitis in the index shoulder,
- Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
- Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
- History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
- History of malignant tumor and osseous metastatic disease,
- History of heterotopic ossification,
- History of chronic pain disorders (i.e., fibromyalgia),
- Current substance abuse (drug or alcohol), by the investigator's judgment,
- For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or...
- Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or...
- Currently involved in any injury litigation or workers compensation claims,
- has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.