View clinical trials related to Rotator Cuff Tear.
Filter by:This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement. In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.
This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. The expected benefit is, that patients will have a minimally invasive surgical procedure, only addressing the humeral shaft, however with the biomechanical advantage of a total reverse shoulder prosthesis, meaning, that with a minimally invasive surgery a comparable result as with a regular total shoulder prosthesis is accomplished. Patients will be closely monitored within the study protocol for 18 months and thereafter in regular interval was as with a normal prosthetic followup.
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.
Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.
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.
The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored. The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.
To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods - abduction shoulder brace versus simple arm sling - following 2 common shoulder surgical procedures - rotator cuff repair (RCR) and reverse total shoulder arthroplasty (RTSA) through a prospective randomized clinical trial.
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.
Relevant problems of rotator cuff repair: - High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear. - Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks. Hypothesis: The investigators believe that high tension repair has a higher retear rate than low tension repair, regardless of the tear size. The investigators also believe that abduction of the arm can reduce relevant tension on the repair. But not each repair benefits equally from this. Relevance of this hypothesis: The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can be influenced. In future, if this hypothesis would be true, the repair tension could be reduced intraoperative by release, side-to-side (margin convergence) repair or medialization of the footprint and thereby convert a high risk to a low risk tension repair. Moreover, it could be that patients with a low tension repair does not necessarily have to wear an abduction splint. And on the other hand, high tension repair patients should probably wear the abduction splint longer with gradually reduction. Approach: The present research plan focused on a new intraoperative (arthroscopic) determinable parameter ("repair tension" on footprint in 0° and 40° abduction) to determine the risk of recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative defined as "reparable". Therefore, the tension of the repaired tendon is measured intraoperative with a spring balance (newtonmeter) and correlated with the postoperative retear-rate. • Measure intraoperative repair tension with the arm in 0° and 40° of abduction
The overall goal of doing this study is to improve long term patient function and outcomes in the healing rates of Rotator Cuffs. The investigators would also like to see if this method can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.