Clinical trial: An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS (NCT00182299)

Eligibility criteria:
Inclusion Criteria:

        Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical
        examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide
        the classification of rotator cuff tears defined and reassessed at the time of surgery
        (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full
        thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 =
        full thickness defect of three tendons).

        Exclusion Criteria:

          -  Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.

          -  Inability of the surgeon to repair the tear with remaining defect no greater than 10mm
             in diameter,

          -  Inability of the surgeon to repair the tear with less than 1cm of medialization,

          -  Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion,
             Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).

          -  Active joint or systemic infection,

          -  Significant muscle paralysis of the shoulder girdle,

          -  Major medical illness that would preclude undergoing surgery,

          -  Patients who are unwilling or unable to be assessed according to study protocol for
             one year following surgery

          -  Major psychiatric illness, developmental handicap or inability to read and understand
             the English language
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days.  The patient has had constipation and discomfort with bowel movements since birth.  His symptoms worsened after eating semi-solid foods.  Vital signs are normal.  Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds.  Xray with barium shows a narrow rectum and rectosigmoid area.  The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine.

Patient description (patient's own words): My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine.

Does the patient match the trial criteria? Contradiction