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Rotator Cuff Injuries clinical trials

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NCT ID: NCT03362320 Active, not recruiting - Rotator Cuff Tear Clinical Trials

Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Start date: June 18, 2015
Phase: N/A
Study type: Interventional

Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

NCT ID: NCT03358316 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head

Start date: January 1, 2018
Phase: N/A
Study type: Observational

To evaluate the association between rotator cuff tear and the proximal migration of humeral head

NCT ID: NCT03353272 Completed - Shoulder Pain Clinical Trials

The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain

Start date: September 18, 2018
Phase: N/A
Study type: Interventional

Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process. Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).

NCT ID: NCT03352180 Recruiting - Clinical trials for Massive Rotator Cuff Tears

Subscapularis Tears in Large to Massive Rotator Cuff Tear

Start date: November 21, 2017
Phase: N/A
Study type: Interventional

Do concomitant subscapularis tears in large to massive rotator cuff tears affect postoperative functional and structural outcomes? Background and purpose: The subscarpularis tendon is essential force maintaining normal glenohumeral biomechanics. However, there are few studies which have addressed the outcomes of tears extending to the subscapularis tendon in massive rotator cuff tears. The purpose of this study was to assess the clinical and structural outcomes of arthroscopic reapair of massive rotator cuff tears involving the subscapulrais.

NCT ID: NCT03339492 Terminated - Clinical trials for Full-thickness Rotator Cuff Tear

PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

RCStim
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis states that exposure to a pulsed electromagnetic field (PEMF) following surgical repair of a full thickness rotator cuff tendon tear reduces tendon re-tear rates. The strength of the shoulder muscles and the levels of pain in subjects after surgical repair of their rotator cuff adjunctively treated with an active PEMF device will also be measured.

NCT ID: NCT03332238 Active, not recruiting - Rotator Cuff Tear Clinical Trials

Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

NCT ID: NCT03326466 Active, not recruiting - Clinical trials for Subacromial Impingement Syndrome

Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).

Start date: November 13, 2017
Phase:
Study type: Observational

In this case-control study, the investigators compare shoulder muscle function, pain, and central nervous system sensitization in patients with Subacromial Pain (SAP) to that in healthy controls. The investigators also examine if a relationship exists between shoulder symptom duration and central sensitization, shoulder muscle function and shoulder pain distribution in patients with SAP.

NCT ID: NCT03319784 Withdrawn - Diabetes Mellitus Clinical Trials

Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients

Start date: September 5, 2018
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03318627 Withdrawn - Rotator Cuff Tear Clinical Trials

Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears

TENS-RCT
Start date: July 6, 2020
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03303001 Completed - Clinical trials for Subacromial Impingement Syndrome

Comparison Between Subacromial Infiltrations

Start date: October 10, 2017
Phase: N/A
Study type: Interventional

The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected in activities of daily living and in laborer absent. One of the first treatment lines is the steroid infiltration for pain relieve, however in several times is only effective by a short period of time, and the symptoms usually appear again. One of the not known infiltration is the high volumen infiltration in subacromial space, this treatment appears to be an effective treatment for this patients.