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Rotator Cuff Tear clinical trials

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NCT ID: NCT03380533 Completed - Rotator Cuff Tear Clinical Trials

Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Start date: September 22, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral opioids) currently used according to the pain management guidelines is insufficient for most of these patients. There are few reports on the use of buprenorphine in post-operative pain with encouraging results. There is no evidence of its use in the management of post-operative pain of arthroscopic rotator cuff repair

NCT ID: NCT03379636 Completed - Rotator Cuff Tear Clinical Trials

Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery

Start date: January 7, 2013
Phase: N/A
Study type: Interventional

Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment but minimal evidence supports its use. The aim of this study is to determine the immediate and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after rotator cuff surgery. Our hypotheses were that KT should not improve muscle function, mobility, strength or pain in a clinically meaningful way. Methods: Thirty-nine subjects with shoulder rotator cuff surgery were tested 6 and 12 weeks post-surgery, without tape, with KT and with a sham tape (ST). KT and ST were applied in a randomized order. For each condition, muscular activity of upper trapezius, three parts of deltoid and infraspinatus during shoulder flexion, range of motion (ROM) and pain intensity were assessed. At 12 weeks, isometric strength at 90° of shoulder flexion, with related muscular activity and pain intensity were also measured. Subjects maintained the last tape applied for three days and recorded pain intensity at wake-up and during the day.

NCT ID: NCT03379324 Recruiting - Rotator Cuff Tear Clinical Trials

Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study

Start date: March 24, 2017
Phase: N/A
Study type: Interventional

Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of repair in the supraspinatus muscle body medial to the musculotendonous junction.

NCT ID: NCT03373799 Completed - Rotator Cuff Tear Clinical Trials

Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears

Start date: May 30, 2016
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.

NCT ID: NCT03362424 Suspended - Rotator Cuff Tear Clinical Trials

Mesenchymal Stem Cells in Rotator Cuff Repair

Start date: November 1, 2020
Phase: Phase 2
Study type: Interventional

Randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).

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: 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: 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