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Shoulder Disease clinical trials

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NCT ID: NCT05284357 Recruiting - Shoulder Disease Clinical Trials

Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term

Start date: April 7, 2022
Phase:
Study type: Observational

This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges. Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail. The retrospective data were collected in a paper CRF via the medical file of patient. Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes. Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

NCT ID: NCT05153863 Completed - Shoulder Injuries Clinical Trials

C Scope Visualization System Prospective Study

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

Evaluation of the performance and safety of the C Scope Visualization System

NCT ID: NCT04538690 Recruiting - Exercise Clinical Trials

The Effect of Exercise Therapy in Painful Shoulder Disorders

Start date: September 15, 2020
Phase: N/A
Study type: Interventional

20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.

NCT ID: NCT04209504 Recruiting - Shoulder Pain Clinical Trials

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

Start date: October 12, 2021
Phase:
Study type: Observational

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

NCT ID: NCT04185064 Completed - Shoulder Injuries Clinical Trials

Cryopneumatic Device After Shoulder Surgeries

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

This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. The primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. Patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. Patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the RCT.

NCT ID: NCT04093700 Terminated - Shoulder Pain Clinical Trials

MDR SureLock All-Suture Anchor

Start date: November 5, 2019
Phase:
Study type: Observational [Patient Registry]

To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.

NCT ID: NCT04003311 Enrolling by invitation - Shoulder Pain Clinical Trials

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Start date: December 13, 2019
Phase:
Study type: Observational

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

NCT ID: NCT04003272 Enrolling by invitation - Shoulder Pain Clinical Trials

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Start date: October 28, 2019
Phase:
Study type: Observational

The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

NCT ID: NCT03956316 Completed - Shoulder Disease Clinical Trials

Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System

Start date: October 15, 2014
Phase:
Study type: Observational

The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.

NCT ID: NCT03877835 Completed - Shoulder Disease Clinical Trials

Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.