Suture Anchor Comparison in Rotator Cuff Repairs

This is an interventional treatment trial for Rotator Cuff Injury focused on measuring Rotator cuff, Ossification, Suture anchors Read More

Inclusion Criteria:

• Male or female, aged 35 to 75 years at the time of surgery.
• Willing and able to give voluntary informed consent to participate in this investigation.
• Full thickness tear of the rotator cuff
• Tear requires repair within one year of initial diagnosis.
• Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity).
• Willing and able, in the opinion of the Investigator, to cooperate with study procedures, and willing to return to study site for all required post-operative study visits.

Exclusion Criteria:

• Evidence of acute trauma including fracture or dislocation of the shoulder joint.
• Chronic retraction.
• Evidence of active infection, osteomyelitis, sepsis or distant infection, which could spread to the index joint.
• Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder.
• Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date.
• Evidence of osteomalacia or other metabolic bone disorder(s), which may impair bone or soft tissue function.
• Evidence of other significant shoulder pathology including (Type II-IV lesion, Bankart lesion, Hill Sachs lesion).
• Patient has grade 4 changes to articular cartilage in operative shoulder
• Inflammatory arthropathies.
• Significant muscle paralysis of the shoulder girdle.
• Painful pathologies of the cervical spine.
• Comminuted bone surface, which would compromise secure anchor fixation.
• Non-surgical rotator cuff associated treatment, such as corticosteroid injection, within one (1) month prior to scheduled surgery date.
• Participating in another investigational trial or ongoing study that would interfere with the assessment of the primary and secondary outcomes.
• Female patient who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
• Major psychiatric illness, developmental handicap or inability to read and understand the English language.
• Major medical illness that would preclude undergoing surgery.
• Known to be involved in any active injury litigation claims relating to the study shoulder.
• Unwilling or unable to be assessed according to study protocol for two years following surgery.
• Patient requires a concomitant SLAP repair procedure in operative shoulder.
• Surgeon plans to use a Platelet Rich Plasma product or another therapy intended to augment healing of the rotator cuff in the study procedure.
• Protocol specified surgical technique cannot be followed for this subject.
• Rotator cuff repair will be done via open (as opposed to arthroscopic) procedure.
• Any other reason (in the judgment of the investigator).