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Rotator Cuff Tear clinical trials

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NCT ID: NCT04062838 Withdrawn - Rotator Cuff Tear Clinical Trials

Prolotherapy for the Treatment of Partial Rotator Cuff Tears

Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement. In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.

NCT ID: NCT03967847 Completed - Postoperative Pain Clinical Trials

Oral Ketorolac for Arthroscopic Rotator Cuff Repair

Start date: February 11, 2019
Phase: Phase 3
Study type: Interventional

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair. 2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.

NCT ID: NCT03924063 Withdrawn - Rotator Cuff Tear Clinical Trials

Safety of the Hemiverse Shoulder Prothesis

Hemiverse
Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. The expected benefit is, that patients will have a minimally invasive surgical procedure, only addressing the humeral shaft, however with the biomechanical advantage of a total reverse shoulder prosthesis, meaning, that with a minimally invasive surgery a comparable result as with a regular total shoulder prosthesis is accomplished. Patients will be closely monitored within the study protocol for 18 months and thereafter in regular interval was as with a normal prosthetic followup.

NCT ID: NCT03916198 Completed - Rotator Cuff Tear Clinical Trials

Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

Start date: May 9, 2019
Phase: Phase 4
Study type: Interventional

This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.

NCT ID: NCT03914703 Completed - Rotator Cuff Tear Clinical Trials

MDR EZ Pass and Precision Flexible Reamer

Start date: August 8, 2019
Phase:
Study type: Observational

The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation. Ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

NCT ID: NCT03913611 Recruiting - Rotator Cuff Tear Clinical Trials

Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

S-START
Start date: October 18, 2019
Phase: N/A
Study type: Interventional

This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. Null hypothesis: There is no difference in outcome between standard rehabilitation and accelerated rehabilitation after arthroscopic rotator cuff repair. Following surgery, they will be randomised to one of two groups: 1. Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme. 2. Accelerated rehabilitation with no requirement to use a sling and a structured exercise programme. The primary outcome measure will be the Oxford Shoulder Score at 6 months. We will also collect data on postoperative pain, range of shoulder movement and other subjective outcome measures. All patients will have MRI scans at 6 months postoperatively to assess the integrity of the repair, allowing comparison of failure rates between groups.

NCT ID: NCT03906630 Completed - Rotator Cuff Tear Clinical Trials

Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

Start date: August 19, 2019
Phase:
Study type: Observational

The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.

NCT ID: NCT03894761 Completed - Shoulder Pain Clinical Trials

Night Pain in Patients With Rotator Cuff Syndrome

Start date: March 21, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

NCT ID: NCT03878862 Recruiting - Rotator Cuff Tear Clinical Trials

Surgical Management of Irreparable RC Tears

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

The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

NCT ID: NCT03838666 Terminated - Rotator Cuff Tear Clinical Trials

Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy

AMSC-RC-001
Start date: December 12, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.