View clinical trials related to Rotator Cuff Injury.
Filter by:This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
The primary objective is to determine whether adjunct treatment using bone marrow aspirate concentrate (BMAC) in conjunction with arthroscopic repair of rotator cuff tears reduces retear rates compared to a control population undergoing arthroscopic repair without BMAC administration. The secondary objectives are to (1) evaluate the survival and incorporation of BMAC labeled cells with MRI imaging using the Ferumoxytol infusion stem cell labeling technique, and (2) determine if administration of BMAC leads to better clinical outcomes as measured by ASES, UCLA and Constant scoring metrics.
Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Patient information about kidney function, current diabetic medication type, dose and frequency will be obtained in clinic. If there is a diagnosed kidney function abnormality, the patient will be excluded from the study. Patients will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3 months, the patient will have HbA1C checked in the lab either same day as the injection or the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac) injection group (n=30) and or Steroid injection group (n=30). The randomization will be done using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm. Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Continuous blood glucose measurement will be started in an hour within the injection. An instructional session about continuous glucose monitoring will be given to the patients by our research team immediately following the injection. The blood glucose levels will be monitored for 1 week following the injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.