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Rotator Cuff Tears clinical trials

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NCT ID: NCT04136743 Recruiting - Clinical trials for Spinal Cord Injuries

Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury

MFAT-SCI
Start date: June 14, 2019
Phase: Phase 2
Study type: Interventional

Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Corticosteroid injections are another alternative to provide temporary relief, but can over time accelerate degeneration of the tendon and lead to further damage. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI compared with the standard-of-care, corticosteroid injection.

NCT ID: NCT04094298 Recruiting - Rotator Cuff Tears Clinical Trials

Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease

Start date: July 15, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.

NCT ID: NCT04077190 Completed - Rotator Cuff Tears Clinical Trials

Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

NCT ID: NCT04061057 Completed - Rotator Cuff Tears Clinical Trials

Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.

NCT ID: NCT04057833 Active, not recruiting - Safety Issues Clinical Trials

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

Start date: November 20, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.

NCT ID: NCT04047745 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Post-operative Exparel Study Following Rotator Cuff Repair

Start date: September 2019
Phase: N/A
Study type: Interventional

The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

NCT ID: NCT04044196 Completed - Rotator Cuff Tears Clinical Trials

Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

Start date: May 1, 2018
Phase:
Study type: Observational

The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.

NCT ID: NCT04025736 Completed - Rotator Cuff Tears Clinical Trials

Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Start date: June 7, 2017
Phase: N/A
Study type: Interventional

Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade 1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.

NCT ID: NCT03985839 Active, not recruiting - Rotator Cuff Tears Clinical Trials

Safety and Performance of MICRORAPTORâ„¢ Suture Anchors in Shoulder and Hip

Start date: August 1, 2019
Phase:
Study type: Observational

This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.

NCT ID: NCT03982108 Completed - Rotator Cuff Tears Clinical Trials

Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique

Start date: May 3, 2017
Phase: N/A
Study type: Interventional

Suture-bridge technique has been widely used for rotator cuff tears with many studies showing superior clinical results and lower failure rates compared to other techniques. This study aims to compare clinical outcomes and radiological integrity of arthroscopic rotator cuff repair between knot-tying and knotless suture-bridge techniques. The possibility of tendon strangulation and necrosis at the medial row when performing a suture-bridge technique may lead to retear and structural failure. In order to avoid this complication, the knots used at the medial row and their tension might be a factor to consider. Our hypothesis is that a knotless suture-bridge technique might avoid tendon strangulation thus might have lower retear rates.