LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
Rotator Cuff Tear
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Large Rotator Cuff Tear, Massive Rotator Cuff Tear, ECM, Extracellular Matrix, ArthroFLEX
Eligibility Criteria
Inclusion Criteria:
- Patients with a large (3-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on pre-operative MRI and US.
- Patients who are willing and able to provide written informed consent for their involvement in the study.
- Patients who meet criteria for RCR surgery
- Patients older than 18 years of age
Exclusion Criteria:
- Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
- Patients with bacteremia, a systemic infection, or infection of the surgical site.
- All those who are prisoners.
- Patients who are pregnant or nursing.
- All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.
Sites / Locations
- Cleveland Clinic FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Other
Control Group
Treatment Group
Crossover Group
Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used.
Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair and the surgeon will use the ArthroFLEX® ECM graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff.
Patients initially randomized to the control arm who cannot be repaired without an augmented graft will be followed for safety and remain in the study and put into a group for the intention to treat.