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Rotator Cuff Injuries clinical trials

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NCT ID: NCT03717571 Completed - Clinical trials for Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears

ROTCUFF
Start date: October 4, 2018
Phase:
Study type: Observational

Degenerative partial and complete rupture of the rotator cuff is a common injury among elder patients. However, the clinical manifestation varies largely with some patients having severe pain and limiting range of motion and others having no complaints. The basic functions of the rotator cuff are to facilitate shoulder motion and stabilization and centering of the glenohumeral joint. The objective of this study is to quantify the difference in superior glenohumeral translation in patients with degenerative rotator cuff tear compared to healthy control subjects and to determine the effect of isolated complete supraspinatus tear and combined complete supraspinatus and either partial infraspinatus or partial subscapularis tear.

NCT ID: NCT03692546 Completed - Postoperative Pain Clinical Trials

Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.

NCT ID: NCT03688308 Withdrawn - Rotator Cuff Tear Clinical Trials

Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03682679 Completed - Rotator Cuff Tear Clinical Trials

Sonoelastography to Predict Rotator Cuff Tears

Start date: October 22, 2018
Phase:
Study type: Observational

Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These problems can be solved by surgeries, but only part of them can be completely repaired. The prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. More and more recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. However, the availability of MRI is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. Because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. This aim of this study is to: 1. check the reliability of sonoelastography. 2. associate the findings of sonoelastography to the results of MRI. 3. build a predictive model for the reparability of large-to-massive rotator cuff tears.

NCT ID: NCT03675399 Completed - Clinical trials for Rotator Cuff Tendinitis

Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain

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

The aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation. To evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and after and 45 minutes after each experimental condition.

NCT ID: NCT03668028 Completed - Clinical trials for Rotator Cuff Injuries

A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Start date: July 9, 2018
Phase: Phase 3
Study type: Interventional

Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (TPX-114) during arthroscopic repair. Secondary outcomes are functional evaluations including Range of Motion (ROM), Constant Score (CS), American Shoulder and Elbow Surgeons (ASES) score and Simple Shoulder Test (SST) at 24 and 52 weeks after administration.

NCT ID: NCT03667833 Completed - Clinical trials for Shoulder Impingement Syndrome

Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture

Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Background: Rounded shoulder posture (RSP), associated with altered scapular kinematics and imbalance of muscle activation, is one of potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of scapula. Evidence showed shoulder brace improved degree of RSP by postural correction. However, it is unknown whether shoulder brace with different characteristics (tension and direction) is optimal for muscle activation and scapular kinematics in patients with SIS and RSP. Objective: There are 4 objectives for the present study: (1) to investigate the relationships among degree of RSP, scapular kinematics and muscle activation in SIS patients with RSP; (2) to compare the effect of shoulder brace on degree of RSP, muscle balance ratios (Upper trapezius/Lower trapezius, Upper trapezius/ Serratus anterior) and scapular kinematics (upward/downward rotation, anterior/posterior tilt, external/internal rotation) during arm movements; (3) to compare the effect of two tensions of brace strap (self-comfortable and forced tension) in symptomatic impingement patients with RSP; (4) to compare the effect of two types of direction of strap (paraspinal muscle and diagonal orientation) in symptomatic impingement patients with RSP. Design: Patients with SIS and RSP will be recruited in this study. Participants will be randomly assigned into 2 groups (self-comfortable following forced tension and forced following self-comfortable tension groups) with 2 directions of strap in each tension wearing shoulder brace. Each patient has the assessment 2 times with 1-week interval. Pectoralis minor, acromial distance, scapular index and shoulder angle will be used to assess degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography muscle activity will be used to record the scapular kinematic, absolute muscle activation and muscular balance ratios during arm movements with or without shoulder brace. Main outcome measures: Scapula kinematic (upward/downward rotation, anterior/posterior tilt, external/internal rotation), absolute muscle activation (Upper trapezius, Middle Trapezius, Lower trapezius, Serratus anterior) and muscle balance ratios (Upper trapezius/Lower trapezius, Upper trapezius/Serratus anterior) are main outcomes of the study.

NCT ID: NCT03663036 Completed - Rotator Cuff Tear Clinical Trials

Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

An irreparable rotator cuff tear (IRCT) is a challenge, with a controversial definition and different treatment options. None of the latter are exempt of limitations and their survivorship is one of the concerns. In 2013, Mihata et al. proposed a novel treatment option: arthroscopic superior capsular reconstruction using a fascia lata autograft (FL-ASCR) harvested through an open approach. Although no harvest site dysfunction was reported, concerns about donor site morbidity discouraged the use of this type of graft. In 2015, the investigators modified the original FL-ASCR introducing a minimally invasive fascia lata harvesting technique, aiming to reproduce FL-ASCR's promising clinical results in IRCT, while reducing donor site morbidity. The investigators aim to: 1) Evaluate the mid-term outcomes and donor site morbidity impact of FL-ASCR with minimally invasive harvesting; 2) Analyze the mid-term graft integrity to determine its survivorship 3) Establish clinical and imaging graft integrity correlations to guide the future treatment algorithm.

NCT ID: NCT03658707 Recruiting - Clinical trials for Subacromial Impingement Syndrome

Validity and Reliability of the Turkish Version of the Functional Shoulder Score

Start date: November 23, 2018
Phase:
Study type: Observational

The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).

NCT ID: NCT03648463 Withdrawn - Clinical trials for Osteoarthritis, Knee

Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions

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

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.